01 1Nippon Kayaku
01 1UBENIMEX
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29536
Submission : 2015-07-31
Status : Active
Type : II
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A Bestatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bestatin, including repackagers and relabelers. The FDA regulates Bestatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bestatin 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 Bestatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Bestatin supplier is an individual or a company that provides Bestatin active pharmaceutical ingredient (API) or Bestatin finished formulations upon request. The Bestatin suppliers may include Bestatin API manufacturers, exporters, distributors and traders.
click here to find a list of Bestatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Bestatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Bestatin active pharmaceutical ingredient (API) in detail. Different forms of Bestatin DMFs exist exist since differing nations have different regulations, such as Bestatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bestatin DMF submitted to regulatory agencies in the US is known as a USDMF. Bestatin USDMF includes data on Bestatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bestatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bestatin suppliers with USDMF on PharmaCompass.
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