Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
01 1CHLORAMBUCIL
01 1India
01 1Active
01 1Complete
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-01
Pay. Date : 2015-09-09
DMF Number : 28956
Submission : 2015-05-25
Status : Active
Type : II
A Chlorambucil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlorambucil, including repackagers and relabelers. The FDA regulates Chlorambucil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlorambucil 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 Chlorambucil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chlorambucil supplier is an individual or a company that provides Chlorambucil active pharmaceutical ingredient (API) or Chlorambucil finished formulations upon request. The Chlorambucil suppliers may include Chlorambucil API manufacturers, exporters, distributors and traders.
click here to find a list of Chlorambucil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chlorambucil DMF (Drug Master File) is a document detailing the whole manufacturing process of Chlorambucil active pharmaceutical ingredient (API) in detail. Different forms of Chlorambucil DMFs exist exist since differing nations have different regulations, such as Chlorambucil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chlorambucil DMF submitted to regulatory agencies in the US is known as a USDMF. Chlorambucil USDMF includes data on Chlorambucil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chlorambucil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chlorambucil suppliers with USDMF on PharmaCompass.
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