FOOD & DRUG ADMINISTRATION MAHARASHTRA STATE, MUMBA I 400 051

CERTIFICATE OF A PHARMACEUTICAL PRODUCT

This certificate conforms to the format recommended by the World Health Organisation
(General instructions and explanatory notes attached)
No. of certificate COPP/CERTMD/80693/2019/11/26440/137132 Valid Upto :23 Oct 2021
Exporting Country INDIA
Importing Country COSTA RICA
I. Name and dosage form of product MUSCORILO
Thiocolchicoside Injection 4 mg/2m1
1.1 Active ingredient(s)2 and amount (s) per unit dose 3: Each 2 ml Am. rule contains
Thiocolchicoside 4 mg Water for injection 1P qs

For complete qualitative composition including excipients :4 As per Annexure

1.2 Is this product licensed to be placed on the market for use in the exporting country ? 5 Yes IZ No
❑ 1.3 Is this product actually on the market in the exporting country ? Yes Ii No ❑ Unknown
❑ 7
ZA.1 Number of product license: 1032951n Form 28 25.1 Applicant for certificate (name and
and date of issue: 08 Jul 2008 address)

2A.Z Product License holder (Name and address)

M. J. BIOPI-IARM PVT. LTD. PLOT NO. L 7, MIDC INDUSTRIAL 2112 Status of applicant :
AREA, TALOJA, RAIGAD 410208 MAHARASHTRA STATE, INDIA A ❑ B E
2A.3 Status of product-license Holder :8 c❑
2B.2.1 For categories b and c the name and address of the manufacturer
A kk C ❑ producing the dosage form is9
2A.3.1 For categories b and c the name and address of the manufacturer
producing the dosage form is:9
is marketing authorization lacking ?
El
2B.3. n ❑

2A.4 Is summary basis of Approval appended ?I° Not required Not requested Under Consideration Refused
2B.4 Remarks :13
Y es 0 N o [Z I

2A.5 Is the attached, officially approved product information complete and

consonant with the license 711
Yes ❑ No ❑ Not Provided El
2A.6 Applicant for cenificate if different from License holder :12
Not Applicable

3. Does the certifying authority arrange for periodic inspection of the manufacturinHant in
which
if no or not applicable proceed to question 4. Yes El Nu
Applicable 14
❑ Not
age form is pr

3.1 Periodicity of routine inspections(years) : Once a year

3.2 Has the manufacture of this type of dosage form been inspected ? Yes El No 4,
❑
3.3 Do the facilities and operations conform to GM? as recommended by World Health Organisation ?15
Yes El Noll Not Applicable 14❑
4. Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product
?I'S
Yes Z No 111
I f no, explain
Ad dre ss of ce rtifying author ity Name of the Authorised person : A. T. NIKHADE
Food & Drug Administration, M.S.
Bandra-kurla Complex,
Signature :
Bandra (E), Mumbai 400 051,
Stamp and Date : Joint Commissioner (HQ) & C trolling
Maharashtra,INDIA.
Tel: +91-22-26592363/64/65 Authority
Fax: +91-22-25591959 Food & Drug Administration, M.S.
5GJM12713069320190107059 Bandra (E), Mumbai.
Maharashtra State, India
Date:07 Jan 2019

0 7 JAN 2019
GENERAL INSTRUCTION :

Please refer to the guidelines for full instruction on how to complete this form and information on the implementation of the
scheme The forms are suitable for generation by computer. They should always be submitted as hard copy, with responses
printed in type rather than hand wri(tenAdditional sheets should be appended, as necessary, to accommodate remarks and
explanations

EXPLANATORY NOTES

1. This certificate, which is in the format recommended by WHO, establishes the status of the pharmaceutical product and of
the applicant for the certificate in the exporting country It is for a single product only since manufacturing arrangements and
approved information for different dosage forms and different strengths can vary.
2. Use, whenever possible, International Nonproprietary Names (INNS) or national nonproprietary names,
3. The formula (complete composition) of the dosage form should be given on the certificate or be appended.
4. Details of quantitative composition are preferred, but their provision is subject to the agreement of the product- Licence
holder.
5_ When applicable, append details of any restriction applied to the sale, distribution, or administration of the product that is
specified in the product Licence.
6, Sections 2A and 2B are mutually exclusive.
7. indicate, when applicable, if the Licence is provisional or the product has not yet been approved.
8. Specify whether the person responsible for placing the product on the market :
(a) manufactures the dosages form
(b) packages and f or labels a dosage form manufactured by an independent. company : er
(c) is involved in none of the above .
9. This information can be provided only with the consent of the product - Licence holder or, in the case of non- registered
products, the applicant . Non-completion of this section indicates that the party concerned has not agreed to inclusion of
this information.it should be noted that information concerning the site of production is part of the product Licence. It the
production site is changed the Licence must be updated or it will cease to be valid.
10. This refers to the document, prepared by some national regulatory authorities, that summarizes the technical basis on
which the product has been licensed.
11. This refers to product information approved by the competent national regulatory authority, such as a summary of product
characteristics (SPC).
12. In this circumstance, permission for issuing the certificate is required from the product Licence holder. This permission must
be provided to the authority by the applicant.
13. Please indicate the reason that the applicant has provided for not requesting registration:
(a) the product has been developed exclusively for the treatment of conditions — particularly tropical diseases — not
endemic in the country of export:
(b) the product has been reformulated with a view to improving its stability under tropical conditions:
(c) the product has been reformulated to exclude excipients not approved for use in pharmaceutical products in the
country of import:
(d) the product has been reformulated to meet a different maximum dosage limit for an active ingredient
(e) any other reason, please specify.
14. Not applicable means that the manufacture is taking place in a country other than that issuing the product certificate and
Inspection is conducted under the aegis of the country of manufacture.
15. The requirements for good practices in the manufacture and quality control of drugs referred to the certificate are those
included in the thirty- second report of the Expert Committee on specifications for Pharmaceutical Preparations (WHO
Technical Report Series, No.823 , 1992 , Annex 1) Recommendations specifically applicable to biological products have
been formulated by the WHO Expert Committee on Biological Standardizati• -.4rov ": t 1.4 • i , 4

.410' I Report Series , Na 822,

1992, Annex 1).
18, The Section is to be completed when the product - licence holder or a • 'iv' conforms to
teg r (c) as described in
note B above. It is of particular importance when foreign contrail t are involved in the menu f the product In
these circumstances the applicant should supply the certifying r.l F i ity with information to identif
Ar
ntractinq parties
responsible for each stage of manufacture of the finished dos fibrin and the and nature of y trols exercised
over each of these parties. NZ (

cf‘from the Divisloqgiug Manager

The layout for this Model Certificate is available on diskette in Word
Health Organization, 1211 Geneva 27, Switzerland.
 FOOD & DRUG ADMINISTRATION MAHARASHTRA STATE, MUMBAI 400 051
CERTIFICATE OF A PHARMACEUTICAL PRODUCT
Annexure of Excipients

No. of certificate COPP/CERT/KD/80693/2019111/26440/137132 VALID LIP TO :23 Oct 2021

Name of the M. J. BIOPHARM PVT. LTD. PLOT NO. L 7, MIDC INDUSTRIAL AREA,
Company TALOJA, RAIGAD 410208 MAHARASHTRA STATE, INDIA
Name and dosage MUSCORIL®
form of product Thiocolchicoside Injection 4 mgaml

Sr.No. Ingredients Specification Qty/Units

1 Sodium Chloride EP 16.8 mg
2 Hydrochloric Acid (Conc.) IH qs
3 Water for Injection IP qs

".*°.

4r,

Address of certifying authority Food 2 1 . 1 0 . . . . . . .

& Drug Administration, M.S.
Bandra-kurla Complex, Name of the Authorised person : A. T. NIKHADE
Bandra (E), Mumbai — 400 051,
Maharashtra,INDIA. StampSignature :
and Date : Joint Commissioner (HQ) & C trolling
Authority
Tel: +91-22-26592363/64
Fax: +91-22-26591959 Food & Drug Administration, M.S.
5G14121806932019C107059 Bandra (E), Mumbal,
Maharashtra State, India
Date:07 Jan 2019

0 1 JAN 2019