01 1SIGMA TAU
01 1TRIZMA HYDROCHLORIDE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4919
Submission : 1983-04-25
Status : Inactive
Type : II
A Tris Hydrochloride API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tris Hydrochloride API, including repackagers and relabelers. The FDA regulates Tris Hydrochloride API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tris Hydrochloride API 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 Tris Hydrochloride API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tris Hydrochloride API supplier is an individual or a company that provides Tris Hydrochloride API active pharmaceutical ingredient (API) or Tris Hydrochloride API finished formulations upon request. The Tris Hydrochloride API suppliers may include Tris Hydrochloride API API manufacturers, exporters, distributors and traders.
click here to find a list of Tris Hydrochloride API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tris Hydrochloride API DMF (Drug Master File) is a document detailing the whole manufacturing process of Tris Hydrochloride API active pharmaceutical ingredient (API) in detail. Different forms of Tris Hydrochloride API DMFs exist exist since differing nations have different regulations, such as Tris Hydrochloride API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tris Hydrochloride API DMF submitted to regulatory agencies in the US is known as a USDMF. Tris Hydrochloride API USDMF includes data on Tris Hydrochloride API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tris Hydrochloride API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tris Hydrochloride API suppliers with USDMF on PharmaCompass.
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