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 1Megafine Pharma (P) Limited
06 1Omgene Life Sciences
07 2Alembic Pharmaceuticals Limited
08 1Apicore LLC
09 1Apotex Pharmachem
10 1Beijing Mesochem Technology
11 1CHEMO
12 1Deva Holding AS
13 1HONOUR LAB LTD
14 1Haoyuan Chemexpress Co.Ltd
15 1Hetero Drugs
16 1MSN Laboratories
17 3Maithri Drugs
18 1Shilpa Medicare
19 1Sionc Pharmaceuticals
20 1Symed Labs
21 1Teva API
22 1Viatris
23 1Zhejiang Ausun Pharmaceutical
24 1Zhejiang Huayi Pharmaceutical Co., Ltd.
01 1Canada
02 4China
03 17India
04 1Israel
05 1Spain
06 1Turkey
07 2U.S.A
01 10Active
02 17Blank
01 27Blank
01 27Blank
01 1WC-0082
02 1WC-0082A11
03 1WC-0273A3
04 1WC-0407
05 23Blank
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.
Megafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.
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 : 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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