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 1Saiming Pharmaceutical
03 1Dr. Reddy's Laboratories
04 1TAPI Technology & API Services
05 1Sichuan Qingmu Pharmaceutical
06 1Alembic Pharmaceuticals Limited
07 1Changzhou Pharmaceutical Factory
08 1Fujian Fukang Pharmaceutical
09 1Globe Quimica Ltda
10 1Hetero Drugs
11 1Jiangsu Lianhuan Pharmaceutical
12 2MSN Laboratories
13 1Macleods Pharmaceuticals Limited
14 1Sichuan Elixir Pharmaceuticals
15 1Synthimed Labs
16 1Blank
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01 1Brazil
02 6China
03 8India
04 1Israel
05 1Blank
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01 7Active
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01 17Blank
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01 17Blank
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01 1WC-0349
02 16Blank
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01 154893-0107
02 168554-0140
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Saiming Pharmaceutical – Delivering innovative, sustainable chemical solutions with global reach and 12+ years of trusted excellence.
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.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-04-20
Pay. Date : 2023-03-30
DMF Number : 37912
Submission : 2023-03-30
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 : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42127
Submission : 2025-06-30
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43200
Submission : 2025-12-15
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43955
Submission : 2026-03-30
Status : Active
Type : II

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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, and more, enabling you to easily find the right Darolutamide manufacturer or Darolutamide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Darolutamide manufacturer or Darolutamide supplier.
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, and COA 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, and COA related information on PharmaCompass.
We have 15 companies offering Darolutamide
Get in contact with the supplier of your choice: