01 1JRS Pharma
01 1LUBRITAB®
01 1Germany
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12549
Submission : 1997-06-07
Status : Active
Type : IV
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PharmaCompass offers a list of Tristearin 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 Tristearin manufacturer or Tristearin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tristearin manufacturer or Tristearin supplier.
A Tristearin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tristearin, including repackagers and relabelers. The FDA regulates Tristearin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tristearin 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 Tristearin supplier is an individual or a company that provides Tristearin active pharmaceutical ingredient (API) or Tristearin finished formulations upon request. The Tristearin suppliers may include Tristearin API manufacturers, exporters, distributors and traders.
click here to find a list of Tristearin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Tristearin DMF (Drug Master File) is a document detailing the whole manufacturing process of Tristearin active pharmaceutical ingredient (API) in detail. Different forms of Tristearin DMFs exist exist since differing nations have different regulations, such as Tristearin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tristearin DMF submitted to regulatory agencies in the US is known as a USDMF. Tristearin USDMF includes data on Tristearin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tristearin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tristearin suppliers with USDMF on PharmaCompass.
