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01 1Fermion Oy
02 1Dr. Reddy's Laboratories
03 1Shandong Loncom Pharmaceutical
04 1TAPI Technology & API Services
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01 1WC-0349
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01 1Su212-7-ND
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01 154893-0107
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Registrant Name : 바이엘코리아(주)
Registration Date : 2020-05-27
Registration Number : Su212-7-ND
Manufacturer Name : Fermion Oy
Manufacturer Address : Orioninkatu 2, Hanko FI-10900 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.
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 : 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
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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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Darolutamide manufacturer or Darolutamide supplier.
PharmaCompass also assists you with knowing the Darolutamide API Price utilized in the formulation of products. Darolutamide API Price is not always fixed or binding as the Darolutamide Price is obtained through a variety of data sources. The Darolutamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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 11 companies offering Darolutamide
Get in contact with the supplier of your choice: