PRIMARY PRODUCT REGISTRATION

PRODUCT NAME

Molnupiravir INN 400 mg Capsule

SUBMITTED BY
EVEREST Pharmaceuticals Ltd.
Kanchpur BSCIC, Soanragon, Narayanagnj
BANGLADESH

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 FORM DA – 1/88

APPLICATION FORM FOR THE REGISTRATION OF DRUGS

(WHICH ARE INCLUDED AS MONOGRAPH IN USP/USPC/USP-NF/INT.PH.OR ALREADY
INTRODUCED IN BANGLADESH)

01. Name and address of the Manufacturer

EVEREST Pharmaceuticals Ltd.
Kanchpur BSCIC, Soanragon, Narayanagnj

02. Manufacturing Licence Number

a) Biological : 178
b) Non-Biological : 336

03 Name of the Drugs

a) Generic Name: Molnupiravir INN

b) Name under which the drug is proposed to be sold: To be submitted at the time of inclusion.

04. Product Data Sheet

a) Presentation: Each Capsule contains Molnupiravir INN 400 mg, Will be packed in Alu-Alu
Blister

b) Uses:
Molnupiravir is clinically effective for the treatment of mild-to-moderate COVID-19.

c) Dosage and Administration:

Molnupiravir 400 mg twice daily for 5 days is recommended and treatment should be initiated within
seven days of symptom onset.

d) Contraindications:

Molnupiravir may be limited to patients at high risk of developing severe disease

e) Precautions:

Monitoring at regular intervals should be done.

f) Drug Interactions:
No data regarding the interactions of Molnupiravir was found.

g) Side Effects:

Molnupiravir is possibly safe when taken by mouth. No side effects have been reported.

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 h) Mechanism of Action:

Molnupiravir increases the frequency of viral RNA mutations and impairs SARS-CoV-2 replication in
animal models and in patients. Molnupiravir induced RNA mutagenesis by the RNA-dependent RNA
polymerase (RdRp) of the coronavirus SARS-CoV-2. Biochemical assays show that the RdRp readily
uses the active form of molnupiravir, β-D-N4-hydroxycytidine (NHC) triphosphate, as a substrate
instead of CTP or UTP. Incorporation of NHC monophosphate into nascent RNA does not impair
further RdRp progression. When the RdRp uses the resulting RNA as a template, NHC directs
incorporation of either G or A, leading to mutated RNA products. Structural analysis of RdRp-RNA
complexes containing mutagenesis products shows that NHC can form stable base pairs with either G
or A in the RdRp active center, explaining how the polymerase escapes proofreading and synthesizes
mutated RNA. This two-step mutagenesis mechanism likely applies to various viral polymerases and
can explain the broad-spectrum antiviral activity of molnupiravir.

i) Package quantities:

To be submitted at the time of inclusion

05. Technical Data

a) Composition/Formula
Ingredients Specifications Quantity/ Function of
Capsule Excipients

Active Ingredient
Molnupiravir
INN 400.000 mg Active

Excipients

Mannitol Spray Dried BP 24.000 mg Filler

Sodium Starch Glycolate BP 12.000 mg Binder

Colloidal Anhydrous Silica BP 6.000 mg Glidant

Magnesium Stearate BP 8.000 mg Lubricant

Empty Hard Gelatin Capsule

Pharma Grade 1 pc Primary Packaging
Shell, Size #0

b) Manufacturing Instructions:

Step-1: Start the operation when the Room Temperature reaches below 250C and the Relative
Humidity reaches below 60%.
Step-2: Sieve Molnupiravir, Mannitol Spray Dried, Sodium Starch Glycolate through a Vibratory
Sifter fitted with 40 mesh SS screen and transfer into a Suitable Blender.

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Step -3: Sieve Magnesium Stearate and Colloidal Anhydrous Silica through 80 mesh SS screen and
transfer into the same blender of Step-2.
Step-4: Mix the contents of Step-3 for 10 minutes in the blender. Check the LOD of the Blend.
Step -5: Inform Quality Assurance Department to collect samples for blend analysis.
Step -6: After getting approval from Quality Assurance Department, encapsulate the blend into
Empty Hard Gelatin Capsule Shell, Size # 0 by maintaining the Room Temperature at
below 250C and the Relative Humidity below 50%.
Step-7: Inform Quality Assurance Department to collect samples of capsules for determining
average weight of content per capsule, weight variation, size, appearance, disintegration
time as per specifications.
Step -8: After getting release from Quality Assurance Department continue the encapsulation.
Step-9: Polish the capsules and collect the polished capsules in an air tight, light resistant and
double polyethylene lined container. Keep with proper labeling and dried Silica Gel bag
inside
Step-10: Inform Quality Assurance Department to collect sample for analysis.
Step-11: After getting approval from Quality Assurance Department, blister the capsules properly in
controlled environment.

6. a) Number of manufacturer already manufacturing this product in Bangladesh:

N/A

b) Estimated market of this product in Bangladesh:

N/A

c) Control data for the active ingredient:

Content of Molnupiravir/Capsule: Molnupiravir INN 400 mg

d) Stability data:
Submitted
e) Proposed shelf life:
2 years

7. a) Proposed Maximum Retail Price ( MRP ):

As fixed by the government of Bangladesh.
b) Estimated price per dose per day treatment & cost for the recommended courses of
treatment:

All depends on the prescription recommended by the physician.

08. a) Particulars of Head of Production

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 Full Name : Shah Galib Eftekhar
Qualification : M. Pharm.
Date of Joining in the applicant Company : 02.11.2019
Total experience in the Pharmaceutical Industries: 10 Years
Registration No. : A-5728

Signature : _________________

b) Particulars of Head of Product Development

Full Name : Md. Ruknuzzaman Rony

Qualification : M. Pharm.
Date of Joining in the applicant Company : 05.05.2019
Total experience in the Pharmaceutical Industries: 15 Years
Registration No. : A-2754

Signature : _________________

c) Particulars of Head of Quality Assurance

Full Name : Afroza Akter

Qualification : M. Pharm.
Date of Joining in the applicant Company : 26.12.2020
Total experience in the Pharmaceutical Industries: 25 Years
Registration No. : A-1545

Signature : _________________

09 : Date of Submission :

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