Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
01 2Granules India Limited
02 2IOL Chemicals and Pharmaceuticals
03 4USV Private Limited
04 2Farmhispania
05 1TAPI Technology & API Services
06 1Aarti Drugs
07 1Auro Laboratories
08 1Aurobindo Pharma Limited
09 1Bausch Health
10 1Exemed Pharmaceuticals
11 1Hainan Poly Pharm
12 1Harman Finochem
13 1Indoco Remedies Limited
14 1Ions Pharma
15 2Ipca Laboratories
16 1KUNSHAN DOUBLE CRANE PHARMACEUTICAL CO LTD
17 2Karo Pharma
18 1Kothari Phytochemicals & Industries
19 1Laurus Labs
20 1Lupin Ltd
21 1Macleods Pharmaceuticals Limited
22 1Marksans Pharma
23 4Merck Sante SAS
24 1Ningxia Heng Kang Pharmaceutical
25 1Ningxia Hengkang Technology
26 1Olon S.p.A
27 1SHANGHAI MEDICINAL LTD
28 1SOHAN HEALTHCARE PVT LTD
29 2Shandong Keyuan Pharmaceutical
30 1Shouguang Fukang Pharmaceutical Co., Ltd
31 1Smruthi Organics
32 1Sun Pharmaceutical Industries Limited
33 1Tianjin Pacific Chemical & Pharmaceutical Co., Ltd
34 1UQUIFA
35 5Wanbury Limited
36 1Wockhardt
37 3Blank
01 1BLENDED METFORMIN HCL
02 1COMPRESSO MF 95P
03 1GLUCOPHAGE 850 MG, FILM-COATED TABLETS
04 1GLUCOPHAGE XR 500 MG, PROLONGED RELEASE TABLETS – BULK (REDUCED MASS)
05 1METFORMIN ( LA-6023),500MG.&850MG. TABLETS
06 1METFORMIN AQ 1000 MG EXTENDED RELEASE TABLETS
07 1METFORMIN DC 92.6% LUBRICATED GRANULES
08 1METFORMIN HCL USP
09 19METFORMIN HYDROCHLORIDE
10 1METFORMIN HYDROCHLORIDE USP
11 1METFORMIN HYDROCHLORIDE (2ND LINE)
12 1METFORMIN HYDROCHLORIDE + 0.5% MAGNESIUM STEARATE
13 1METFORMIN HYDROCHLORIDE DC GRADE - 90%
14 1METFORMIN HYDROCHLORIDE DC GRADE - 95%
15 1METFORMIN HYDROCHLORIDE DC GRANULES
16 1METFORMIN HYDROCHLORIDE DRUG SUBSTANCE
17 1METFORMIN HYDROCHLORIDE DRUG SUBTANCE
18 1METFORMIN HYDROCHLORIDE EXTENDED RELEASE TABLETS
19 13METFORMIN HYDROCHLORIDE USP
20 1METFORMIN HYDROCHLORIDE USP (COARSE)
21 1METFORMIN HYDROCHLORIDE USP (PROCESS II)
22 1METFORMIN HYDROCHLORIDE USP (PROCESS-II)
23 1METFORMIN HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE
24 1METFORMIN SR GRADE 70%
25 1Metformin Hydrochloride USP, as maufactured in Raigad District, INDIA
01 1Canada
02 9China
03 4France
04 31India
05 1Israel
06 1Italy
07 3Spain
08 2Sweden
09 3Blank
01 39Active
02 16Inactive
01 16Complete
02 39Blank
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-28
Pay. Date : 2016-07-01
DMF Number : 16625
Submission : 2003-06-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27139
Submission : 2013-05-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-11
Pay. Date : 2013-06-27
DMF Number : 12647
Submission : 1997-09-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13869
Submission : 1998-11-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13827
Submission : 1998-11-09
Status : Inactive
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17723
Submission : 2004-09-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-21
Pay. Date : 2020-10-29
DMF Number : 35265
Submission : 2020-10-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17744
Submission : 2004-10-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17743
Submission : 2004-10-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15557
Submission : 2001-08-01
Status : Active
Type : II
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