01 1TopChem Pharmaceuticals
02 1Blank
01 2BRETYLIUM TOSYLATE
01 1Ireland
02 1Blank
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25937
Submission : 2012-04-20
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2729
Submission : 1976-09-03
Status : Inactive
Type : II
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A Bretylium Tosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bretylium Tosylate, including repackagers and relabelers. The FDA regulates Bretylium Tosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bretylium Tosylate 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 Bretylium Tosylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bretylium Tosylate supplier is an individual or a company that provides Bretylium Tosylate active pharmaceutical ingredient (API) or Bretylium Tosylate finished formulations upon request. The Bretylium Tosylate suppliers may include Bretylium Tosylate API manufacturers, exporters, distributors and traders.
click here to find a list of Bretylium Tosylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bretylium Tosylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Bretylium Tosylate active pharmaceutical ingredient (API) in detail. Different forms of Bretylium Tosylate DMFs exist exist since differing nations have different regulations, such as Bretylium Tosylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bretylium Tosylate DMF submitted to regulatory agencies in the US is known as a USDMF. Bretylium Tosylate USDMF includes data on Bretylium Tosylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bretylium Tosylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bretylium Tosylate suppliers with USDMF on PharmaCompass.
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