DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 2Dr. Reddy's Laboratories
02 1Porton Pharma Solutions
03 1Alembic Pharmaceuticals Limited
04 1Aurisco Pharmaceutical
05 1Aurobindo Pharma Limited
06 1Beijing Hope Pharmaceutical
07 1Hetero Drugs
08 1Laurus Labs
09 1MSN Laboratories
10 1Zydus Lifesciences
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-28
Pay. Date : 2020-09-30
DMF Number : 34667
Submission : 2020-03-24
Status :
Type : II
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39029
Submission : 2023-11-02
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35740
Submission : 2021-03-25
Status :
Type : II
A Apalutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apalutamide, including repackagers and relabelers. The FDA regulates Apalutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apalutamide 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 Apalutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Apalutamide supplier is an individual or a company that provides Apalutamide active pharmaceutical ingredient (API) or Apalutamide finished formulations upon request. The Apalutamide suppliers may include Apalutamide API manufacturers, exporters, distributors and traders.
click here to find a list of Apalutamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Apalutamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Apalutamide active pharmaceutical ingredient (API) in detail. Different forms of Apalutamide DMFs exist exist since differing nations have different regulations, such as Apalutamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Apalutamide DMF submitted to regulatory agencies in the US is known as a USDMF. Apalutamide USDMF includes data on Apalutamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Apalutamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Apalutamide suppliers with USDMF on PharmaCompass.
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