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 1Aarti Drugs
08 1Actavis Inc
09 1Alembic Pharmaceuticals Limited
10 1Arevipharma
11 1Aspire Lifesciences Pvt Ltd
12 1AstraZeneca
13 1Atul Bioscience Ltd
14 1Aurobindo Pharma Limited
15 1CTX Lifesciences
16 1Esteve Quimica
17 1Freemen Nutra
18 1Guangzhou Tosun Pharmaceutical
19 1HEC Pharm
20 2Hetero Drugs
21 1Hoventa Pharma
22 1Indoco Remedies Limited
23 2Ipca Laboratories
24 1Kopran
25 1MSN Laboratories
26 1Macleods Pharmaceuticals Limited
27 1Nishchem International Pvt. Ltd
28 1Osmopharm
29 1Parshwanath Life Sciences
30 1Pellets Pharma Limited
31 1Polydrug Laboratories Private Limited
32 1Reine Lifescience
33 1Saneca Pharmaceuticals
34 2Sun Pharmaceutical Industries Limited
35 1Syn-Tech Chem. & Pharm
36 1Teva API
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 11Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 3Withdrawn by Holder
04 37Blank
01 52Blank
01 1WC-0011
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 2WC-0220
11 1WC-0390
12 1WC-0457A3
13 1WC-0526
14 1WC-390A4
15 37Blank
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
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
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 |
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
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-21
Pay. Date : 2019-07-22
DMF Number : 27915
Submission : 2014-03-11
Status : Active
Type : II
Certificate Number : CEP 2014-038 - Rev 01
Issue Date : 2023-11-17
Type : Chemical
Substance Number : 1448
Status : Valid
NDC Package Code : 49587-114
Start Marketing Date : 2019-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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