Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
01 2Granules India Limited
02 1Emay Pharmaceuticals
03 1Metrochem API Private Limited
04 2Dr. Reddy's Laboratories
05 1Moehs Iberica
06 1HRV Global Life Sciences
07 1TAPI Technology & API Services
08 1Aarti Drugs
09 1Actavis Inc
10 1Alembic Pharmaceuticals Limited
11 1Arevipharma
12 1Aspire Lifesciences Pvt Ltd
13 1AstraZeneca
14 1Atul Bioscience Ltd
15 1Aurobindo Pharma Limited
16 1CTX Lifesciences
17 1Esteve Quimica
18 1Freemen Nutra
19 1Guangzhou Tosun Pharmaceutical
20 1HEC Pharm
21 2Hetero Drugs
22 1Hoventa Pharma
23 1Indoco Remedies Limited
24 2Ipca Laboratories
25 1Kopran
26 1MSN Laboratories
27 1Macleods Pharmaceuticals Limited
28 1Nishchem International Pvt. Ltd
29 1Osmopharm
30 1Parshwanath Life Sciences
31 1Pellets Pharma Limited
32 1Polydrug Laboratories Private Limited
33 1Reine Lifescience
34 1Saneca Pharmaceuticals
35 2Sun Pharmaceutical Industries Limited
36 1Syn-Tech Chem. & Pharm
37 1Teva Pharmaceutical Industries
38 1Titan Laboratories
39 1Unichem Laboratories Limited
40 2YUNG ZIP CHEMICAL INDUSTRIAL
41 1Zentiva
42 1Zhejiang Apeloa Jiayuan Pharmaceutical
43 1Zhejiang Hisoar Pharmaceutical
44 1Zhejiang Huahai Pharmaceutical
45 1Zhejiang Yongtai Technology
46 1Zydus Lifesciences
01 7China
02 1Czech Republic
03 1Germany
04 32India
05 1Ireland
06 2Israel
07 1Slovakia
08 2Spain
09 1Switzerland
10 3Taiwan
11 1United Kingdom
01 25Active
02 9Inactive
03 18Blank
01 13Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 3Withdrawn by Holder
04 35Blank
01 52Blank
01 1WC-0011nA2
02 1WC-0040
03 1WC-0040A3
04 1WC-0062
05 1WC-0081
06 1WC-0091
07 1WC-0097
08 1WC-0120
09 1WC-0159
10 1WC-0220
11 1WC-0390
12 1WC-0457A3
13 1WC-0526
14 1WC-390A4
15 38Blank
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-05-27
Pay. Date : 2021-04-19
DMF Number : 33544
Submission : 2019-03-27
Status : Active
Type : II
Certificate Number : CEP 2019-232 - Rev 02
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 1448
Status : Valid
Date of Issue : 2022-05-02
Valid Till : 2025-05-01
Written Confirmation Number : WC-0526
Address of the Firm :
NDC Package Code : 62207-970
Start Marketing Date : 2021-03-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ROW, ASMF |
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-03-19
Pay. Date : 2024-02-28
DMF Number : 18348
Submission : 2005-05-13
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-11-30
Written Confirmation Number : WC-0390
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-12
Pay. Date : 2013-09-23
DMF Number : 16621
Submission : 2003-06-19
Status : Active
Type : II
Certificate Number : CEP 2004-202 - Rev 07
Issue Date : 2024-02-27
Type : Chemical
Substance Number : 1448
Status : Valid
NDC Package Code : 52932-0713
Start Marketing Date : 2009-09-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-04
Pay. Date : 2013-06-19
DMF Number : 14612
Submission : 1999-12-09
Status : Active
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 : 35959
Submission : 2021-06-13
Status : Active
Type : II
NDC Package Code : 62207-970
Start Marketing Date : 2021-03-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ROW, ASMF |
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-09-30
Valid Till : 2025-11-30
Written Confirmation Number : WC-390A4
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-15
Pay. Date : 2016-09-23
DMF Number : 29954
Submission : 2015-11-30
Status : Active
Type : II
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