01 1Hetero Drugs
02 1MSN Laboratories
01 2AMIFAMPRIDINE PHOSPHATE
01 2India
01 2Active
01 2Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-06
Pay. Date : 2022-09-15
DMF Number : 37447
Submission : 2022-09-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-08
Pay. Date : 2022-06-14
DMF Number : 34624
Submission : 2020-02-29
Status : Active
Type : II
A Amifampridine Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amifampridine Phosphate, including repackagers and relabelers. The FDA regulates Amifampridine Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amifampridine Phosphate 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 Amifampridine Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amifampridine Phosphate supplier is an individual or a company that provides Amifampridine Phosphate active pharmaceutical ingredient (API) or Amifampridine Phosphate finished formulations upon request. The Amifampridine Phosphate suppliers may include Amifampridine Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Amifampridine Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amifampridine Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Amifampridine Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Amifampridine Phosphate DMFs exist exist since differing nations have different regulations, such as Amifampridine Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amifampridine Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Amifampridine Phosphate USDMF includes data on Amifampridine Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amifampridine Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amifampridine Phosphate suppliers with USDMF on PharmaCompass.
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