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Food and Drugs Administration (M.S,)
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FOOD ANO DRUG
AOMINISTRANON Tel:Q22-26592362_65
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E-Mail : comm.fda-mah@nic.in

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Office of The Commissioner,

Food & Drugs Administration M.S.
Bandra - Kurla Complex,
Bandra (E),
Mumbai - 400 051
Daie: Zg loS le0 I:F

C.ERTIFICATE OF GOOD MANUFACTUBING PRACTICPS

This Certificate conforms to the format recommended by the World Health Organization.
(General instructions and explanatory notes attached).
Ce rlificate N o. : N EW-WHO-G M P/C E RT/KD/S5508/20 1 7/1 1 /1 9339

On the basis of the inspection carried out on 1413117 AND 1513117 ,we certify that the site
indicated on this Certificate complies with Good Manufacturing Practices for the dosage
forms, categories and activities listed in Table 1.
1. Name of the Firm : SHEFA HEALTHCARE PVT. LTD.
Address , A-1Ol1t MIDC, TALOJA INDUSTRIAL AREA,
VILLAGE.PEND TAL.PANVEL RAIGAD 41O2O8
MAHARASHTRA STATE, INDIA
2. Licence No. . KD598 In Form 25,
KD41 8 ln Form 28

Table 1

Sr.No. Dosage Form(s) Categor(ies) Activity(ies)

1 General ( Other than rroduction, Filling, Packing,
iquid Orals Cephalosporins, Penicillin, abelling, Quality Control,
Cytotoxic, Hormones ) f,ualitv Assurance
2 3eneral ( Other than troduction, Filling, Packing,
fablets Sephalosporins, Penicillin, abelling, Quality Control,
lytotoxic, Hormones ) Qualitv Assurance

The responsibility for the quality of the individual batches of the pharmaceutical products
manufactured through this process lies with the manufacturer.

This certificate remains valid until 19 May 2019 . lt becomes invalid if the activities and / or
categories certified herewith are changed or if the site is no longer considered to be in
compliance with GMP.

Address of certifying authority : Name of the Authorised person :O S SADHWANI

Food & Drug Administration, M.S.
Bandra-kurla Complex,
^;Ra:r1Jr/
Bandra (E), Mumbai - 400 051. Stamp and €Ele :Joint Commissioner (HQ) & Controlling
Maharashtra,lNDlA. Authority
fel: +9 1 -22-26592 36 3/64
Fax. +91-22-26591959
1EHS3805550820170520
':y*^'--K Food & Drug Administration, M.S.
Bandra (E), Mumbai.
Maharashtra State, India
i1
$i1 Date:2O May 2017
f 1t;

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Explanatory notes

1. This certificate which is in the format recommended by WHO, certifies the status of the site listed
in point I of the certificate.

Z. The certification number should be traceable within the regulatory authority issuing the
, certificate.

3. Where the regulatory authority issues a licence for tl're site, this number should be specified
record "not applicabie" in cases where there is no legal framework for the issuing of a licence,

4. Table I
List tl-re dosage forms, starting materials, categories and activities. Examples are given below.

Examnle -l
Pharmaceutical Product (s) t Category (ies) Activity (ies)
Dosage form (s)
Tablets Cvtotoxic Packasins
Hormone Production, Packaging, QualitY
control.
lniectables Penicillin Repackaging & Labelling.
Cefalosporin Aseptic preparation, Packaging,
Labellins.

Example - 2.

Pharmaceutical Product (s) t Category (ies) Activity ( ies )

Starting material (s)z
Paracetamol AnulsHffi{; *Eftkmn.
Synthesis, Purifi cation,
Labelline.

Use, whenever available, ational r\ \rr lPr uP (INNs) or otherwise national

Blllu*.'
nonproprietarynames. ii

5. The cerlificate remains ntif tfra*p.ecinea 0",".', f" certificate becomes invalid if the
activities and/or catego fied are changed or if ih8lsite is no longer considered to be in
compliance with GMP. i
.n'd*i
+ ,'[
6. The requirements for good the manu fac+ile. diid quality control of drugs referred to in
the certificate are those incl l$h"l8. of Pharmaceuticals: a compendium of
suidelines and related materialsl ring practices and inspection. Volume 2,
1999. World Health Organization, Getteva and subsequent updates'
 LIST OF PRODUCT APPROVED UNDERWHO GMPI
No, of certificate NEW-WHO-GMP/CERT/KD/5550812017111 vALrDUpro:19 May2019
t19339
Name of l\llanufactring Firm : SHEFA HEALTHCARE PVT. LTD.
A.1O/1, MIDC, TALOJA INDUSTRIAL AREA,
VILLAGE-PEND TAL-PANVEL RAIGAD 410208
MAHARASHTRA STATE. INDIA
Drug License No I(D598 In Form 25.
I(D418 In Form 28

Sr.No. Name of the Product Composition

1 Vlaxmol Tablet Each Tablet contains
)aracetamol Tablet BP 500mg Paracetamol BP 500 mg

) )andamol syrup 120 Each 5 ml contains

)aracetamol Syrup BP Paracetamol BP 120 mg
In a flavoured Syrupy base

Address of certifying authority : Name of the Authorised person : O S SADHWANI

Food & Drug Administration, M.S.
Bandra-kurla Complex. Sig natu
Bandra (E), Mumbai - 400 051
Stamp and ioner (HQ) & Gontrolling Authority
Maharashtra,IND lA.
.# Food & Drug Administration, M.S.

r--xs
Tel +9 1 -22-26592363/64
Fax: +91-22-26591959 Bandra (E), Mumbai.
1 E HS3805550820 1705 20 Maharashtra State, India
Date:2O May 2017
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