01 1HAS Healthcare Advanced Synthesis
02 1SAFC
01 2MECHLORETHAMINE HYDROCHLORIDE
01 1Switzerland
02 1U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37687
Submission : 2023-04-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10103
Submission : 1993-02-22
Status : Inactive
Type : II
A Mechlorethamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mechlorethamine, including repackagers and relabelers. The FDA regulates Mechlorethamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mechlorethamine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Mechlorethamine supplier is an individual or a company that provides Mechlorethamine active pharmaceutical ingredient (API) or Mechlorethamine finished formulations upon request. The Mechlorethamine suppliers may include Mechlorethamine API manufacturers, exporters, distributors and traders.
click here to find a list of Mechlorethamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mechlorethamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Mechlorethamine active pharmaceutical ingredient (API) in detail. Different forms of Mechlorethamine DMFs exist exist since differing nations have different regulations, such as Mechlorethamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mechlorethamine DMF submitted to regulatory agencies in the US is known as a USDMF. Mechlorethamine USDMF includes data on Mechlorethamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mechlorethamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mechlorethamine suppliers with USDMF on PharmaCompass.
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