Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
01 1Granules India Limited
02 1LGM Pharma
03 1Fermion Oy
04 1Cohance Lifesciences
05 2Fareva
06 1Jai Radhe Sales
07 1Chynops Pharma
08 1HRV Global Life Sciences
09 1Ami Organics Private Limited
10 2Angelini Pharma
11 1Arene Lifesciences
12 1Cube Research Laboratories
13 1Erregierre SpA
14 1Glenmark Life Sciences
15 1Gokulendu Life Science
16 1Guangzhou Tosun Pharmaceutical
17 1Intas Pharmaceuticals
18 1Ipca Laboratories
19 1LifeFirst Pharma
20 1MSN Laboratories
21 1Maisuriya Pharma Solutions
22 1Maithili Life Sciences
23 2Medilux Laboratories
24 1Nifty Labs
25 1Piramal Pharma Solutions
26 1Reine Lifescience
27 1SGMR Pharmaceuticals
28 1SPC Lifesciences Pvt. Ltd
29 1Sharon Bio-Medicine Limited
30 1Sms Lifesciences
31 1Synergene Active Ingredients Pvt Ltd
32 2Teva API
33 1Teva Pharmaceutical Industries
34 1Tooba Pharmaceuticals
35 1Vera Laboratories Ltd IN 500 004 Hyderabad
36 1Viatris
37 1Zydus Lifesciences
38 3Blank
01 1China
02 1Finland
03 28India
04 3Israel
05 3Italy
06 2Luxembourg
07 3U.S.A
08 3Blank
01 13Active
02 7Inactive
03 24Blank
01 9Valid
02 35Blank
01 1222MF10059
02 1302MF10058
03 42Blank
01 1WC-0015
02 1WC-0024
03 1WC-0123
04 1WC-0153
05 40Blank
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 : 2023-08-22
Pay. Date : 2023-07-17
DMF Number : 37593
Submission : 2022-12-28
Status : Active
Type : II
Certificate Number : CEP 2023-010 - Rev 00
Issue Date : 2024-02-15
Type : Chemical
Substance Number : 2857
Status : Valid
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm :
NDC Package Code : 62207-019
Start Marketing Date : 2023-01-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ROW |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4570
Submission : 1982-05-21
Status : Active
Type : II
Available Reg Filing : ASMF |
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-04
Pay. Date : 2013-09-26
DMF Number : 6721
Submission : 1986-12-01
Status : Active
Type : II
Registration Number : 222MF10059
Registrant's Address : NUERNBERGER STRASSE 12, 90537 FEUCHT, GERMANY
Initial Date of Registration : 2010-02-17
Latest Date of Registration : --
NDC Package Code : 24823-911
Start Marketing Date : 2013-04-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
Registration Number : 302MF10058
Registrant's Address : Parc Industriel d\'Incarville Parc de la Fringale CS 10606 27106 Val de Reuil Cedex France
Initial Date of Registration : 2020-05-19
Latest Date of Registration : --
NDC Package Code : 24823-911
Start Marketing Date : 2013-04-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16207
Submission : 2002-10-25
Status : Inactive
Type : II
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