01 1Catalytica
01 1BUTAMBEN USP
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11781
Submission : 1995-12-19
Status : Inactive
Type : II
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PharmaCompass offers a list of Butamben API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Butamben manufacturer or Butamben supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Butamben manufacturer or Butamben supplier.
A Butamben manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butamben, including repackagers and relabelers. The FDA regulates Butamben manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butamben 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 Butamben manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Butamben supplier is an individual or a company that provides Butamben active pharmaceutical ingredient (API) or Butamben finished formulations upon request. The Butamben suppliers may include Butamben API manufacturers, exporters, distributors and traders.
click here to find a list of Butamben suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Butamben DMF (Drug Master File) is a document detailing the whole manufacturing process of Butamben active pharmaceutical ingredient (API) in detail. Different forms of Butamben DMFs exist exist since differing nations have different regulations, such as Butamben USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Butamben DMF submitted to regulatory agencies in the US is known as a USDMF. Butamben USDMF includes data on Butamben's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Butamben USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Butamben suppliers with USDMF on PharmaCompass.
