01 1Alembic Pharmaceuticals Limited
02 1Hetero Drugs
03 2MSN Laboratories
01 3DAROLUTAMIDE
02 1DAROLUTAMIDE PREMIX
01 4India
01 4Active
01 3Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-20
Pay. Date : 2023-03-30
DMF Number : 37912
Submission : 2023-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-13
Pay. Date : 2023-04-25
DMF Number : 38274
Submission : 2023-05-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-30
Pay. Date : 2023-01-09
DMF Number : 37585
Submission : 2022-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36697
Submission : 2022-02-28
Status : Active
Type : II
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.
A Darolutamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Darolutamide active pharmaceutical ingredient (API) in detail. Different forms of Darolutamide DMFs exist exist since differing nations have different regulations, such as Darolutamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Darolutamide DMF submitted to regulatory agencies in the US is known as a USDMF. Darolutamide USDMF includes data on Darolutamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Darolutamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Darolutamide suppliers with USDMF on PharmaCompass.
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