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 Alkeran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alkeran, including repackagers and relabelers. The FDA regulates Alkeran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alkeran 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 Alkeran manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alkeran supplier is an individual or a company that provides Alkeran active pharmaceutical ingredient (API) or Alkeran finished formulations upon request. The Alkeran suppliers may include Alkeran API manufacturers, exporters, distributors and traders.
click here to find a list of Alkeran suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alkeran DMF (Drug Master File) is a document detailing the whole manufacturing process of Alkeran active pharmaceutical ingredient (API) in detail. Different forms of Alkeran DMFs exist exist since differing nations have different regulations, such as Alkeran USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alkeran DMF submitted to regulatory agencies in the US is known as a USDMF. Alkeran USDMF includes data on Alkeran's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alkeran USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alkeran suppliers with USDMF on PharmaCompass.
We have 4 companies offering Alkeran
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