ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1ChemPacific Corp
04 1Hubei Honch Pharmaceutical
01 2MELPHALAN
02 1MELPHALAN DRUG SUBSTANCE
03 1MELPHALON USP
01 1China
02 1India
03 2U.S.A
01 4Active
01 1Complete
02 3Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21237
Submission : 2008-01-11
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-10
Pay. Date : 2014-05-28
DMF Number : 28300
Submission : 2014-05-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20073
Submission : 2006-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38591
Submission : 2023-10-05
Status : Active
Type : II
A Melphalan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Melphalan, including repackagers and relabelers. The FDA regulates Melphalan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Melphalan 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 Melphalan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Melphalan supplier is an individual or a company that provides Melphalan active pharmaceutical ingredient (API) or Melphalan finished formulations upon request. The Melphalan suppliers may include Melphalan API manufacturers, exporters, distributors and traders.
click here to find a list of Melphalan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Melphalan DMF (Drug Master File) is a document detailing the whole manufacturing process of Melphalan active pharmaceutical ingredient (API) in detail. Different forms of Melphalan DMFs exist exist since differing nations have different regulations, such as Melphalan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Melphalan DMF submitted to regulatory agencies in the US is known as a USDMF. Melphalan USDMF includes data on Melphalan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Melphalan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Melphalan suppliers with USDMF on PharmaCompass.
We have 4 companies offering Melphalan
Get in contact with the supplier of your choice:
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