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 1Omgene Life Sciences Pvt. Ltd
06 2Alembic Pharmaceuticals Limited
07 1Apicore LLC
08 1Apotex Pharmachem
09 1Beijing Mesochem Technology
10 1CHEMO
11 1Deva Holding AS
12 1HONOUR LAB LTD
13 1Haoyuan Chemexpress Co.Ltd
14 1Hetero Drugs
15 1MSN Laboratories
16 3Maithri Drugs
17 1Shilpa Medicare
18 1Sionc Pharmaceuticals
19 1Symed Labs
20 1Viatris
21 1Zhejiang Ausun Pharmaceutical
22 1Zhejiang Huayi Pharmaceutical Co., Ltd.
01 1Canada
02 4China
03 16India
04 1Spain
05 1Turkey
06 2U.S.A
01 10Active
02 15Blank
01 25Blank
01 25Blank
01 1WC-0082
02 1WC-0082A11
03 1WC-0273A3
04 1WC-0407
05 21Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33947
Submission : 2019-06-18
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.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-03-01
Pay. Date : 2019-01-28
DMF Number : 33061
Submission : 2018-12-31
Status : Active
Type : II
NDC Package Code : 69037-0036
Start Marketing Date : 2015-12-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39287
Submission : 2023-12-18
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-23
Pay. Date : 2019-03-20
DMF Number : 32123
Submission : 2017-10-13
Status : Active
Type : II
Date of Issue : 2020-09-09
Valid Till : 2023-06-28
Written Confirmation Number : WC-0407
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33561
Submission : 2019-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36155
Submission : 2021-07-31
Status : Active
Type : II
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