U C OREP

NO"34ACRP/CAB/DG/D11/2024
Congolese Authority of
Forwarded a copy for information to:
Mr. Deputy Director General in
ze Detect
KINSHASA/GOMBE
To Mr. Phcien responsible for
NOOR PHARMA in
LUBUMBASHI/HAUT KATANGA

Mr Pharmacist,

At the end of the evaluation of the files

Subject: Additional information

1 8 a to
technical aspects of your pharmaceutical products, subject to approval with a view to
obtaining marketing authorizations (AMM), additional information is required to “enable the
National Approval Commission to issue a decision on your products ". For which, I would be
grateful if you would submit as soon as possible, as additional information, the various
elements inherent to your products, listed below :
NO Specialties Required documents (electronic) within 45 days

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health ; Decree No. 020/002 of March 5, 2020 relating to the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP
U COREP

I Nordox I. Active ingredient

50mg/5ml 1. In section 3.2.S.2.2 Description of manufacturing
Suspension process and process control
It was noted that you provided a synthesis
scheme not indicating the molecular formulas;
molecular weights; the reagents, catalysts and
solvents used in each step.
Please provide a revised synthesis scheme that
indicates the molecular formulas, molecular
weights, chemical structures, reagents, catalysts,
and solvents used in each step.

2. In section 3.2.S.2.3 Material control

It was found that you did not provide data on the
control of materials used in the manufacture of the
active substance.
Please provide information related to the control of
starting materials. Note that your

".

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health ; Decree No. 020/002 of March 5, 2020 relating to the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP
U COREP
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The response must include the specifications and

certificates of analysis for each starting material , the
list of addresses and names of suppliers of these
starting materials.

3. In section 3. 2.S. 6. Container closing system

It has been noted that you have not included the
identification test in the primary packaging material
specifications.
Please include the identification test in the primary
packaging material specifications .

II. Final product

4. In section 3. 2.P. 2.2.1. Formulation
Development
It has been noted that you have not indicated the
name and manufacturer of the originator used for
the development of your formulation.
Please indicate the name and manufacturer of the
originator that allowed you to develop your
formulation.

5. In section 3.2.P.3.1 Manufacturer(s)

It has been found that you have not indicated the
specific block(s) and/or unit(s) responsible for
manufacturing the Finished product at your facility.
Please indicate the specific block(s) and/or unit(s)
responsible for the synthesis of the finished product
at your facility.

6. In section 3.2.P.3.3 Description of manufacturing

process and process control
It was noted that you did not provide a narrative
description of the manufacturing process for the
finished product. Please provide a narrative
description of the manufacturing process for the
finished product.

7. In section 2.3.P.5.1 Specification(s)

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health ; Decree No. 020/002 of March 5, 2020 relating to the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP
U COREP

It was found that you did not provide finished

product specifications.
Please provide signed and dated specifications of
your finished product. Note that your answer
should include the antimicrobial preservatives
citric acid and benzoate.

Detect fairy
sodium ).
8. Please improve the size of the writing in the
instructions by referring to the original.

9. The image of the baby was noted on the

secondary packaging. Please remove the image of
the baby on the secondary packaging.

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health ; Decree No. 020/002 of March 5, 2020 relating to the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP
U COREP
She

2 Ciprofloxacin I. Active ingredient

500mg / Tinidazole 1. In section 3.2.S.2.3 Control of materials It was
600mg tablet noted that you did not provide the names and
addresses of suppliers of the starting materials as
well as the specifications and certificates of
analysis of these starting materials. Please
provide the names and addresses of suppliers of
starting materials as well as the specifications and
certificates of analysis of these materials.
II. Final product
2. In section 3. 2.P. 7. container closing system
It has been noted that you have not included the
identification test in the primary packaging
material specifications.
Please include test identification in the primary
packaging material specifications.
3. In subsection 3. 2.P. 2.2.1. Formulation
Development
It has been noted that you have not provided the
name and manufacturer of the originator product
used in the formulation of the finished product.
Please provide the name and manufacturer of the
comparator product that allowed you to develop
your formulation.
4. In section 3.2.P.5.1 Specification(s)
It has been noted that you have not provided the

".

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health ; Decree No. 020/002 of March 5, 2020 relating to the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP
U COREP
She

D¿ zec.tewz feetenaC

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. of December 13, 2018 establishing the fundamental principles relating to the organization of Public
18/035

Health ; Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U COREP
She

signed and dated specifications of your finished

product. Please provide signed and dated finished
product specifications with version number.

5. In section 3.2.P.7 Container closing system

It was found that you did not provide the
specifications of the packaging materials

primary of the finished product.

Please provide material specifications for the
primary packaging of the finished product. Note
that your answer must include the identification
test.

6. Please provide the product price excluding

tax

7. Please contact AOREP to organize the audit

of your manufacturing site.
3 Noor Quick tablet I. Active ingredient
1. In section 3.2. S.2.3 Control of Materials It
has been noted that you have not provided the
specifications and certificates of analysis of the
starting materials used in the synthesis of active
substances ( paracetamol , diclofenac ,
chlorpheniramine , magnesium trisilicate ).
Please provide specifications for each starting
material including acceptance limits for organic,
non- specific and total impurities as well as
certificates of analysis for 3 batches of each API
( paracetamol , diclofenac , chlorpheniramine ,
magnesium trisilicate ).

2. In section 3.2.S.6. Reference materials It

was noted that you did not provide the lot

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health ; Decree No. 020/002 of March 5, 2020 relating to the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP
U COREP
She

numbers and the source of origin of the reference

standards (paracetamol, diclofenac ,
chlorpheniramine , magnesium trisilicate ) which
made it possible to qualify the working standards
aracetamol , diclofenac chlorine heniramine

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. of December 13, 2018 establishing the fundamental principles relating to the organization of Public
18/035

Health ; Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U COREP
She

Detect fire

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health ; Decree No. 020/002 of March 5, 2020 relating to the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP
U COREP
She

magnesuim trisilicate ).
Please provide lot numbers and source of
reference standards (paracetamol, diclofenac ,
chlorpheniramine , magnesuim trisilicate ) which
made it possible to qualify the working standards
( paracetamol , diclofenac , chlorpheniramine ,
magnesuim trisilicate ) and IR spectra allowing
qualification of reference and working standards.

3. In section 3.2.S.6 container closure system

It has been noted that you have not provided the
material specifications of the primary packaging
used. Please provide material specifications of the
primary packaging used. Note that your answer
must include the identification test.

II. Final product

4. In section 3.2.P.2.5 Microbiological
attributes It has been noted that you have used
antimicrobial preservatives ( methyl paraben and
propyl paraben ) in the formulation of the finished
product. However, you have not indicated the
concentration, although minimal but effective,
capable of destroying the various germs found in
the finished product.
Please indicate the concentration, whether
minimal but effective, capable of destroying the
various germs found in the finished product.

5. In section 3.2. P.2.1 Formulation

development
It has been noted that you have not provided the

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. of December 13, 2018 establishing the fundamental principles relating to the organization of Public
18/035

Health ; Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U COREP
She

data from the comparative dissolution studies of

your product with the original product.
Please provide comparative dissolution studies in
the three physiological pH 1.2, 4.5 and 6.8 and
analytical media using the already authorized
Relief Tablet from Prince Pharma as a comparator
product.

Detect ClététaC

6. In section 3.2.P.5.1 Specification(s)

It has been found that you have used
preservatives ( soduim methyl paraben and
sodium propyl paraben ) in the formulation of the
finished product.

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health ; Decree No. 020/002 of March 5, 2020 relating to the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP
U COREP
She

However, you have not taken this into account in

the finished product specifications. Please review
finished product specifications to include
antimicrobial preservatives (sodium methyl
paraben and sodium propyl paraben ) among the
parameters to control.

Note that your response must include the dated

and signed specifications with version number,
the analytical procedures, the validation data of
the methods for measuring these parameters
(antimicrobial preservatives) as well as the
stability data carried out for 6 months in
accelerated and at least 12 months in real time
accompanied by a letter of commitment, including
among the parameters to be evaluated the
antimicrobial preservatives (sodium
methylparaben and sodium propylparaben ) and
the certificates of analysis of three batches.

7. In section 3.2.P.6 Reference Standards

It has been noted that you have not provided the
lot numbers of the reference standards
( paracetamol BP, diclofenac BP, chlorpheniramine
maleate BP and magnesium trisilicate BP) which
made it possible to qualify the working standards
(Paracetamol BP: PC/WS/23-24/075, Diclofenac
DS/WS/23-24/076, Chlorpheniramine maleate BP
CM/WS/23-24/077, Magnesium trisilicate
BP: MT/WS/23-24/078).
Please provide the lot numbers of the reference
standards ( paracetamol BP, diclofenac BP,
chlorpheniramine maleate BP and magnesium
trisilicate BP) which made it possible to qualify
the working standards ( Paracetamol BP:
PC/WS/2324/075, Diclofenac BP DS/WS/23-
24/076, Chlorpheniramine maleate BP
CM/WS/23-

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. of December 13, 2018 establishing the fundamental principles relating to the organization of Public
18/035

Health ; Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U COREP
She

24,077 Magnesium BP trisilicate : MT/WS 23-

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health ; Decree No. 020/002 of March 5, 2020 relating to the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP
UCOREP

24/078) and IR spectra allowing the superposition

of working and reference standards.

8. In section 3.2. P.7 container closing system

It was noted that you did not include in the
specifications of the primary packaging
materials used the identification test.

Please include in the specifications of the

materials of the primary packaging used the
identification test.
9. Please improve the size of the writing in
the instructions by referring to the original.

10. Please remove images on secondary

packaging.

11. Please put the storage temperature on the

secondary packaging

12. Please change the name of the finished

product as it could cause confusion with another
already authorized one.

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
No. of December 13, 2018 establishing the fundamental principles relating to the organization of Public
18/035

Health ; Decree No. 020/002 of March 5, 2020 relating to the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP
4 NORITER DP COMPRESSED Final product
1. In section 3.2.P.2.5 Microbiological
Attributes It has been noted that you have used
antimicrobial preservatives ( methyl paraben and
propyl paraben ) in the formulation of the finished
product.
However, you have not indicated the
concentration, although minimal but effective,
capable of destroying the various germs found in
the finished product.
Please indicate the concentration, whether
minimal but effective, capable of destroying the
various germs found in the finished product.

2. In section 3.2.P.2.1 Formulation

development

101

".

P
ha rmac•utique
Deceetccn fairyáaC

It was noted that you provided the comparative

dissolution studies using the Co- Mart forte plus
tablet product from NEM Laboratories . Pvt . Ltd.
Please resume your comparative dissolution
studies using the product Co- artem 80/480
tablets from the company SANOFI in the three
physiological media at pH 1.2, 4.5 and 6.8 and

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
No. of December 13, 2018 establishing the fundamental principles relating to the organization of Public
18/035

Health ; Decree No. 020/002 of March 5, 2020 relating to the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP
U COREP
She

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. of December 13, 2018 establishing the fundamental principles relating to the organization of Public
18/035

Health ; Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
é.bc0REÞ

4. In section 3.2.P.6 Standard Reference

It was noted that you did not provide the batch
number of the reference standards ( artemether
and lumefantrine ) which made it possible to
qualify the working standards ( artemether and
lumefantrine ).
Please provide the batch number of the reference
standards ( artemether and lumefantrine ) which
made it possible to qualify the working standards
( artemether and lumefantrine ) and the IR
spectra allowing the superposition of the working
and reference standards.

5. In section 3.2.P.7 Container closing system

It was noted that you did not include the
identification test in the specifications of the
primary packaging materials. Please include in the
specifications of the primary packaging materials
the identification test .

6. Please improve the size of the writing in the

instructions by referring to the original.

7. Please remove the mosquito image on the

secondary packaging.

8.Please contact ACOREP to arrange the audit of

your manufacturing site.

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
No. of December 13, 2018 establishing the fundamental principles relating to the organization of Public
18/035

Health ; Decree No. 020/002 of March 5, 2020 relating to the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP
U COREP
She

5 Noriter Suspension 180 mg/ Final product

1080 mg/60 ml 1. In section 3.2.P.2.5 Microbiological Attribute It
has been noted that you have used antimicrobial
preservatives (methyl paraben and propyl
paraben ) in the formulation of the finished
product. However, you have not indicated the
concentration, although minimal but effective,
capable of destroying the various germs found in
the finished product.
Please indicate the concentration if minimal -

it but effective capable of destroying the different

erms found in the finished product .

law

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. of December 13, 2018 establishing the fundamental principles relating to the organization of Public
18/035

Health ; Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U
COREP
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D¿zectexa 5ÓtézaC

2. In section 3.2.P.2.1 Development of the

formulation
It was noted that you did not provide the
comparative dissolution studies as well as the
comparator used. This is not acceptable provided

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13 , 2016 establishing the fundamental principles relating to the organization of Public
Health ; Decree No. 020/002 of March 5, 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U
COREP pharmaceutical

that in the tablet form from the same

manufacturer the dissolution studies were
provided with the comparator.
Please provide comparative dissolution studies of
the Norither product susp in the three
physiological environments pH1.2, 4.5 and 6.8
and analytical using as a comparator the product
Lonart suspension product approved in the

country from the firm Bliss Gvsd .

3. In section 3.2.P.5.1 Specification(s)
It has been found that you have used the
preservatives (sodium methyl paraben and
sodium propyl paraben ) in the formulation of the
finished product.
However, you have not taken this into account in
the specifications of the finished product. Which
is not acceptable.
Please review the specifications of the finished
product to include antimicrobial preservatives
(sodium methyl paraben and sodium propyl
paraben ) among the parameters to control.
Note that your response must include the dated
and signed specifications with version number,
the analytical procedures, the validation data of
the methods for measuring these parameters
(antimicrobial preservatives) as well as the
stability data carried out for 6 months in
accelerated and at least 12 months in real time
accompanied by a letter of commitment, including
among the parameters to be evaluated the
antimicrobial preservatives (sodium
methylparaben and sodium propylparaben ) and
the certificates of analysis of three batches.

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. of December 13, 2018 establishing the fundamental principles relating to the organization of Public
18/035

Health ; Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U
COREP Congolese Authority

It was also noted that in the specifications

provided the test arameter is between 90 -

At
Regulations
Pha tick

ze Dhecteta fetezal
110 which is not acceptable. Since the specs are
In House; you need to restrict the limits and
validate the method between 95 and 105.

Please provide revised specifications including the

test parameter with the interval between 95 and
105.

4. In section 3.2.P.6 Reference Standards

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
No. 18/035 of December 13 , 2018 establishing the fundamental principles relating to the organization of Public Health ;
Decree No. 020/002
of March 5 , 2020 establishing the creation, organization and operation of a public establishment
called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U
COREP pharmaceutical

It was noted that you did not provide the batch

number of the reference standards ( artemether
IH and lumefantrine IH) which made it possible to
qualify the working standards ( artemether IH
AMWS-23103 and lumefantrine IH LTWS-23104).
Please provide the lot number of the reference
standards ( artemether IH and lumefantrine IH)
which made it possible to qualify the working
standards ( artemether IH AMWS-23103 and
lumefantrine IH LTWS-23104) as well as the IR
spectra of the working standards and reference.

5. In section 3.2.P.8.3.3 Stability data It was

noted that you did not provide evidence from
studies of the stability of the product after
opening. Please provide evidence of stability
studies after opening the product.

6. Please contact AOREP to organize the audit

of your manufacturing site.

7. Please provide the tax-free wholesale price

of the product

8. Please improve the size of the writing in the

instructions by referring to the original.

9. Please remove the mosquito image on the

secondary packaging.

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. of December 13, 2018 establishing the fundamental principles relating to the organization of Public
18/035

Health ; Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U
COREP Congolese Authority

06 Norzith Oral Suspension USP I. Active ingredient

IOOmg / 5 ml 1. In section 3. 2. S.2.1 manufacturer
specific manufacturing block and /or unit s. eu

101

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
No. 18/035 of December 13 , 2018 establishing the fundamental principles relating to the organization of Public Health ;
Decree No. 020/002
of March 5 , 2020 establishing the creation, organization and operation of a public establishment
called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U
COREP pharmaceutical

responsible for synthesizing the API at your

institution.
Please indicate the specific manufacturing
block(s) and/or unit(s) responsible for
synthesizing the API at your facility.

2. In section 3. 2. S.2.2 Manufacturing description

and process control
It was found that the starting material used in the
synthesis of API is a complex molecule in this
case:
Please redefine the starting materials used to
a simpler molecule and include information
regarding all solvents and reagents used in
case the complex molecule ' Erithromicin ' is
not commercially available.

Please provide the names, addresses of

suppliers of starting materials as well as
specifications and certificates of analysis of all
starting materials used in the synthesis of the
API in case the complex molecule '
Erithromicin ' is available on the market with
its valid GMP certificate as proof that the
complex molecule is GMP compliant.

II. Final product

3. In section 3.2.P.5.1 Specification(s)
It was noted that you did not include in the
finished product specifications the antimicrobial
preservatives (sodium methyl paraben and
sodium propyl paraben ).Which is not acceptable.
Please review the specifications of the finished
product to include antimicrobial preservatives
Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. of December 13, 2018 establishing the fundamental principles relating to the organization of Public
18/035

Health ; Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U
COREP Congolese Authority

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
No. 18/035 of December 13 , 2018 establishing the fundamental principles relating to the organization of Public Health ;
Decree No. 020/002
of March 5 , 2020 establishing the creation, organization and operation of a public establishment
called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U COREP Congolese Authority
Pharmaceutical

Ze

of

Daeetewv féetézaC
parameters (antimicrobial preservatives) as well
as stability data carried out for 6 months in
accelerated fashion and at least 12 months in real
time accompanied by a letter of commitment,
including antimicrobial preservatives (sodium
methylparaben and sodium propylparaben )
among the parameters to be evaluated. and
certificates of analysis for three batches.

It was also noted that you included the

deliverable volume parameter as a parameter in
the specifications of the finished product. This is
not acceptable given that the product submitted
is in the form of a suspension and not in the form
of a spray. Please justify the presence of the
deliverable volume parameter as a parameter in
the finished product specifications.

4. In section 3.2.P.6 Reference standards

It has been noted that you have not provided any
information on the working standard.
Please provide us with information on the
working standards. Note that your response must
include the working standards COA as well as its
IR spectrum.

5. In section 3.2.P.8.3.3 Stability data It was

noted that you did not provide evidence of
product stability studies after opening.
Please provide product stability studies after
opening the bottle, during use.

Address : 66, Boulevard du 30 Juin, 4th level building 5 à sec, Kinshasa/Gombe Ref. In front of the CNSS
No. of December 13 , 2018 establishing the fundamental principles relating to the organization of Public
18/035

Health Decree No. 020/002 of March 5, 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Regulatory Authority Pharmaceutical “ ACOREP ”.
UCORP Congolese Authority

Ze

07 Norzith 500 mg tablet I. Active ingredient

1. In section 3.2.S.2.1 Manufacturer
It has been found that you have not indicated the
specific block(s)/unit(s) responsible for API
synthesis at your institution. Please indicate the
specific manufacturing block(s)/unit(s)
responsible for API synthesis at your facility.

2. In section 3.2.S.2.2 Description manufacturing

law ,

Congolese Authority

Dheeteuz f.é"áac
and Process Control
It was found that the starting material used in the
synthesis of API is a complex molecule. Which is
not acceptable as starting material.
Please redefine the starting material used to a
simpler molecule and include information

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
No. 18/035 of December 13 , 2018 establishing the fundamental principles relating to the organization of Public Health
Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public establishment called the
Congolese Regulatory Authority AOREP Pharmaceuticals ”.
U COREP
Pharmaceutical

Ze

regarding all solvents and reagents used in the

synthesis.

Please provide names; addresses of Starting

Material suppliers as well as specifications and
certificates of analysis of all starting materials
used in the synthesis of the API.
3. In section 3. 2. S.2.3 Control of materials It
has been noted that you have not provided the
specifications of the starting materials used in the
synthesis of the active substance.
Please provide specifications for each starting
material including acceptance limits for organic,
non-specific and total impurities as well as
certificates of analysis for 3 batches.

4. It was also noted that you used ethanol

and acetone in the final stage of the synthesis.
However, these solvents (Ethanol and Acetone)
are likely to be contaminated by benzene. Please
demonstrate that:
you control benzene while providing
specifications for ethanol and acetone to
the acceptable limit of 2 ppm or; the level
of benzene in the API is less than 30 0 /0 of
the acceptable limit (ICH) while providing
the certificates of analysis of the solvents
used protocol and the validation report of
3 commercial batches / or 6 pilot batches
of the API.

II. Final product

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 19/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health Decree No. 020/002 of March 5 , 2020 establishing the creation , organization and operation of a public
establishment called the Congolese Health Authority . “ ACOREP ” Pharmaceutical Regulation .
UCORP Congolese Authority

Ze

Dheeteca 5óeézaC

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
No. 18/035 of December 13 , 2018 establishing the fundamental principles relating to the organization of Public Health
Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public establishment called the
Congolese Regulatory Authority AOREP Pharmaceuticals ”.
U COREP
Pharmaceutical

Ze

4. In section3. 2.P. 2.2.1 Development of the

formulation
It has been noted that you used the product
ZITHROMIN 500 MG as the originator product to
conduct your Bioequivalence studies. However,
this product is not the innovative one. Please use
ZITHROMAX 500 MG CES from Pfizer as an
innovative product instead.

5. In section 3.2.P.6 Standard reference

The Certificate of Analysis (COA) of the working
standard was found not to conform to the
finished product specifications. Which is not
acceptable.
Please provide a standard working COA consistent
with the finished product specifications.

6. In section 3. 2. P.7 Container closing system

It has been noted that you have not included in

the specifications of the primary packaging
materials the identification test as a parameter in
the specifications.
Please therefore include in the specifications of
the primary packaging materials the identification
test among the parameters to be tested.

6. score line was noted on the azithromycin

tablets provided. Please justify with appropriate
studies the functionality of this secability line .

7. Please improve the size of the writing in the

instructions by referring to the original.

8. Please remove the image of the baby on the

secondary packaging.

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 19/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health Decree No. 020/002 of March 5 , 2020 establishing the creation , organization and operation of a public
establishment called the Congolese Health Authority . “ ACOREP ” Pharmaceutical Regulation .
UCORP Congolese Authority

Ze

08 Metrofomet 100mg/100mg Active ingredient

Suspension 1. In section 3.2. S.2.3 Control of materials It has
been noted that you have not provided the
specifications of the raw materials used

IOi ;

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
No. 18/035 of December 13 , 2018 establishing the fundamental principles relating to the organization of Public Health
Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public establishment called the
Congolese Regulatory Authority AOREP Pharmaceuticals ”.
U COREP
She

pha " nawutique

Detectan 5écécaC
in the synthesis of the active substance
( norfloxacin and metronidazole).
Please provide specifications for each starting
material including acceptance limits for organic,
non-specific and total impurities as well as
certificates of analysis for 3 batches.

2. In section 3.2.S.5 standard reference

It has been noted that you have not provided the
certificate of analysis of the working standard of
Norfloxacin which has been qualified against the
reference standard from the European
monograph.
norfloxacin working standard which has been
standardized against the reference standard and
the IR spectra allowing the superposition of the
working and reference standard to be compared.

3. In section 3.2. S.6 container closing system

It was found that you did not provide the material

specifications of the primary packaging of
norfloxacin .
Please provide the material specifications of the
primary packaging of norfloxacin including the
identification test as a parameter in the
specifications. Note that this packaging must
include a certificate attesting that the primary
packaging used meets the packaging
requirements used in the food industry .

II. Final product

4. In section 3. 2.P. 2 Pharmaceutical
Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. of December 13, 2018 establishing the fundamental principles relating to the organization of Public
18/035

Health ; Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
UCORP Congolese Authority

Ze

Development
It was noted that you did not provide evidence of
the minimum inhibitory concentration, however
small it may be, but important for the
preservatives ( methylparaben and propyl
paraben ) present in the formulation of the
finished product .

Detect fetezal

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public establishment
called the Congolese Regulatory Authority Pharmaceutical “ ACOREP ”.
U COREP
Authority • Congolese

Please provide evidence on the minimum

inhibitory concentration of these preservatives.

5. In section 2.3.P.5.1 Specification(s)

It was noted that you did not include in the
finished product specifications the antimicrobial
preservatives (sodium methyl paraben and
sodium propyl paraben ), the deliverable volume
as parameters to be tested. Which is not
acceptable. Please review finished product
specifications to include antimicrobial
preservatives (sodium methyl paraben and
sodium propyl paraben ) among the parameters
to control. Note that your response must include
the dated and signed specifications with version
number, the analytical procedures, the validation
data of the methods for measuring these
parameters (antimicrobial preservatives) as well
as the stability data carried out for 6 months in
accelerated and at least 12 months in real time
accompanied by a letter of commitment,
including among the parameters to be evaluated,
the antimicrobial preservatives (sodium
methylparaben and sodium propylparaben ) and
the analysis certificates for three batches.

6. In section 2.3.P.8.3 Stability Data It was

found that you did. not provided evidence from
studies of the stability of the product after
opening.
Please provide evidence of product stability
studies after opening, during use.

7. The presence of cake formation was noted

in the primary packaging of the finished product.
Please provide COA of finished product with new
samples.

8. Please contact AOREP for the site audit.

Address : 66, Boulevard du 30 Juin, 4th level building 5 à sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13 , 2018 establishing the fundamental principles relating to the organization of public
health ; Decree No. of March 5, 2020 relating to the creation, organization and operation of a public
020/002

establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP

UCORP Congolese Authority

Ze

ze Dézeetewz
9. Please provide the tax-free wholesale price
of the product.

10. It was noted that the indications provided

in the SmPC do not comply with those in the
instructions. Please follow the instructions in the
instructions.

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public establishment
called the Congolese Regulatory Authority Pharmaceutical “ ACOREP ”.
U COREP
Authority • Congolese

09 Metrofomet tablet 200 I. Active ingredient

mg/200mg 1. In section 3. 2.S.2.3 Materials Control It
was noted that you did not provide the
specifications of the starting materials used in the
synthesis of the active substance ( norfloxacin and
metronidazole).
Please provide specifications for each starting
material including acceptance limits for organic,
non-specific and total impurities as well as
certificates of analysis for 3 batches.

2. In section 3. 2. S.6 container closure system

It was found that you did not provide the material
specifications of the primary packaging of
norfloxacin .
Please provide the material specifications of the
primary packaging of norfloxacin including the
identification test.
Note that this packaging must include a certificate
attesting that the primary packaging used meets
the packaging requirements used in the food
industry .

II. Final product

3. In section 3.2. P.3.3 Manufacturing description
and process control
It was noted that you did not provide a narrative
description of the manufacturing process for the
finished product.
Please provide a narrative description of the
manufacturing process for the finished product .

Address : 66, Boulevard du 30 Juin, 4th level building 5 à sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13 , 2018 establishing the fundamental principles relating to the organization of public
health ; Decree No. of March 5, 2020 relating to the creation, organization and operation of a public
020/002

establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP

U COREP
Autorité Congolaise

Regulations

Pharmaceut ze Dheeteuz

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public establishment
called the Congolese Regulatory Authority Pharmaceutical “ ACOREP ”.
U COREP
4. In section 3.2.P.5.1 Specifications
It was noted that you did not include
antimicrobial preservatives (sodium methyl
paraben and sodium propyl paraben ).Which is
not acceptable. Please review finished product
specifications to include antimicrobial
preservatives (sodium methyl paraben and
sodium propyl paraben ) among the parameters
to control.
Note that your response must include the dated
and signed specifications with version number,
the analytical procedures, the validation data of
the methods for measuring these parameters
(antimicrobial preservatives) as well as the
stability data carried out for 6 months in
accelerated and at least 12 months in real time
accompanied by a letter of commitment,
including among the parameters to be evaluated
the antimicrobial preservatives (sodium
methylparaben and sodium propylparaben ) and
the analysis certificates for three batches.

5. In section 3.2.P.6 Reference Standards

It has been noted that you have not provided the
certificates of analysis of the working standards
( Norfloxacin (NF/WS/23-24/021); Metronidazole
(MT/WS/23-24/020)) and reference ( Norfloxacin
USP and Metronidazole BP).
Please provide certificates of analysis for working
standards ( Norfloxacin ).

6. It was noted that the indications provided in the

SmPC do not comply with those in the
instructions. Please harmonize the information
in the SmPC and the package leaflet.

7. Please follow the instructions in the

instructions.
10 Vivax 30mg, 60mg, 120mg, I. Active ingredient

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of
Public Health ; Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U COREP
150mg, 240mg injectable 1. In section 3.2.P.3.5 Validation and/or
Roced evaluation

Pharmaceutical

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public establishment
called the Congolese Regulatory Authority Pharmaceutical “ ACOREP ”.
U COREP
Ze Déteeteaa q.é"ézal

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of
Public Health ; Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U COREP
We were unable to locate information related to
the environmental control and media fill test .
Please provide information on environmental
monitoring as well as media fill test evidence.

2. In section3. 2.P. 5.1 Specification(s)

It was noted that in the specifications provided
the test parameter is between 90 IIO which is not
acceptable. Since the specifications are IH you
must restrict the limits and validate the method
between 95 and 105.
Please provide revised specifications including the
test parameter with the interval between 95 and
105.

3. In section 3.2.P.6 Reference Standards

It was found that you did not provide the
certificate of analysis of the working standard.
Please provide the certificate of analysis of the
working standard as well as copies of the IR
spectra allowing the superposition of the working
and reference standard to be compared.

4. In section 3.2.P.7 Container closing system

It was noted that you did not provide the
specifications of the primary packaging materials
used.
Please provide the specifications and methods of
analysis of the primary packaging materials ( Vials
and rubber) used.

5. It was found that the name of the product

“VIVAX” used is close to the falciparum strain vivax
of the Anopheles mosquito.
Which is not acceptable. Please change the name
of the finished product used.
6. The presence of the mosquito image on the
secondary packaging was noted. Please remove
the mosquito image on the
Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public establishment
called the Congolese Regulatory Authority Pharmaceutical “ ACOREP ”.
U COREP

Indeed, in accordance with the instructions of

His Excellency the Minister of Public Health, cfr Ministerial Order No. 1250
/CAB/MIN/SP/011/CPH/OBF/2015 of September 28, 2015, an audit of your production sites
is required. Which I ask you to please contact ACORP immediately regarding this.
Please accept, Mr. Pharmacist, the expression of
my distinguished feelings.

Christian NTUMBA NGOY

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of
Public Health ; Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public
establishment called the Congolese Pharmaceutical Regulatory Authority “ ACOREP ”.
U COREP

Address : 66, Boulevard du 30 Juin, 4th level building 5 in Sec, Kinshasa/Gombe Ref. In front of the CNSS
Law No. 18/035 of December 13, 2018 establishing the fundamental principles relating to the organization of Public
Health Decree No. 020/002 of March 5 , 2020 establishing the creation, organization and operation of a public establishment
called the Congolese Regulatory Authority Pharmaceutical “ ACOREP ”.