Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1LGM Pharma
03 1Metrochem API Private Limited
04 1Nuray Chemicals Private Limited
05 1HRV Global Life Sciences
06 1Medichem S.A
07 1Shandong Loncom Pharmaceutical
08 1Alembic Pharmaceuticals Limited
09 1Alven Laboratories
10 1Aspire Lifesciences Pvt Ltd
11 1Aurobindo Pharma Limited
12 1Beijing Mesochem Technology
13 1Guangzhou Tosun Pharmaceutical
14 2Johnson & Johnson Innovative Medicine
15 1Kimia Biosciences
16 1MSN Laboratories
17 1Shilpa Medicare
18 1Shouyuan Chemical
19 1Sun Pharmaceutical Industries Limited
20 1Symed Labs
21 1Torrent Pharmaceuticals Limited
01 4China
02 1Czech Republic
03 13India
04 1Spain
05 3U.S.A
01 10Active
02 2Inactive
03 10Blank
01 22Blank
01 22Blank
01 1WC-0147
02 1WC-0349
03 1WC-0382
04 1WC-0416
05 1WC-0474
06 1WC-0493
07 16Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-13
Pay. Date : 2023-09-28
DMF Number : 37576
Submission : 2022-10-31
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-06
Pay. Date : 2022-09-19
DMF Number : 34970
Submission : 2020-08-21
Status : Active
Type : II
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm :
NDC Package Code : 42765-011
Start Marketing Date : 2020-06-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (2kg/2kg)
Marketing Category : BULK INGREDIENT
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-04-04
Pay. Date : 2023-04-17
DMF Number : 36765
Submission : 2022-02-18
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-083
Start Marketing Date : 2021-06-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-08-03
Pay. Date : 2022-06-13
DMF Number : 37181
Submission : 2022-06-13
Status : Active
Type : II
NDC Package Code : 16436-0129
Start Marketing Date : 2022-05-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-21
Pay. Date : 2023-09-25
DMF Number : 38893
Submission : 2023-09-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-12
Pay. Date : 2023-07-26
DMF Number : 34862
Submission : 2020-09-25
Status : Active
Type : II
Date of Issue : 2019-12-02
Valid Till : 2022-08-08
Written Confirmation Number : WC-0382
Address of the Firm :
NDC Package Code : 66022-0207
Start Marketing Date : 2018-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-06-14
Pay. Date : 2023-06-06
DMF Number : 38084
Submission : 2023-06-04
Status : Active
Type : II
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