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 Leukeran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leukeran, including repackagers and relabelers. The FDA regulates Leukeran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leukeran 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 Leukeran manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Leukeran supplier is an individual or a company that provides Leukeran active pharmaceutical ingredient (API) or Leukeran finished formulations upon request. The Leukeran suppliers may include Leukeran API manufacturers, exporters, distributors and traders.
click here to find a list of Leukeran suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Leukeran DMF (Drug Master File) is a document detailing the whole manufacturing process of Leukeran active pharmaceutical ingredient (API) in detail. Different forms of Leukeran DMFs exist exist since differing nations have different regulations, such as Leukeran USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Leukeran DMF submitted to regulatory agencies in the US is known as a USDMF. Leukeran USDMF includes data on Leukeran's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Leukeran USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Leukeran suppliers with USDMF on PharmaCompass.
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