Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Fermion Oy
03 1Dr. Reddy's Laboratories
04 1Shandong Loncom Pharmaceutical
05 1TAPI Technology & API Services
06 1Lee Fine Chem
07 1Sichuan Qingmu Pharmaceutical
08 1Alembic Pharmaceuticals Limited
09 1Changzhou Pharmaceutical Factory
10 1Fujian Fukang Pharmaceutical
11 1Globe Quimica Ltda
12 1Hetero Drugs
13 1Jiangsu Lianhuan Pharmaceutical
14 2MSN Laboratories
15 1Macleods Pharmaceuticals Limited
16 1Synthimed Labs
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01 1Brazil
02 5China
03 1Finland
04 9India
05 1Israel
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01 5Active
02 12Blank
01 17Blank
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01 17Blank
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01 1WC-0349
02 16Blank
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01 1Su212-7-ND
02 16Blank
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01 154893-0107
02 168554-0140
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01 17Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Registrant Name : Bayer Korea Ltd.
Registration Date : 2020-05-27
Registration Number : Su212-7-ND
Manufacturer Name : Fermion Oy
Manufacturer Address : Orioninkatu 2, 10960 Hanko Pohjoinen Finland
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Lee Fine Chem: Advancing Innovation and Quality in Intermediates, APIs, and Dosage Forms for Superior Pharmaceutical Solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36697
Submission : 2022-02-28
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0107
Start Marketing Date : 2021-01-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-30
Pay. Date : 2023-01-09
DMF Number : 37585
Submission : 2022-11-30
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2023-06-13
Pay. Date : 2023-04-25
DMF Number : 38274
Submission : 2023-05-02
Status : Active
Type : II
NDC Package Code : 68554-0140
Start Marketing Date : 2019-07-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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PharmaCompass offers a list of Darolutamide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Darolutamide manufacturer or Darolutamide supplier for your needs.
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A Darolutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Darolutamide, including repackagers and relabelers. The FDA regulates Darolutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Darolutamide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Darolutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Darolutamide supplier is an individual or a company that provides Darolutamide active pharmaceutical ingredient (API) or Darolutamide finished formulations upon request. The Darolutamide suppliers may include Darolutamide API manufacturers, exporters, distributors and traders.
click here to find a list of Darolutamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 16 companies offering Darolutamide
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