01 1Fuxin Long Rui Pharmaceutical
01 1OMARIGLIPTIN
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33488
Submission : 2019-07-08
Status : Active
Type : II
A Omarigliptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Omarigliptin, including repackagers and relabelers. The FDA regulates Omarigliptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Omarigliptin 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 Omarigliptin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Omarigliptin supplier is an individual or a company that provides Omarigliptin active pharmaceutical ingredient (API) or Omarigliptin finished formulations upon request. The Omarigliptin suppliers may include Omarigliptin API manufacturers, exporters, distributors and traders.
click here to find a list of Omarigliptin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Omarigliptin DMF (Drug Master File) is a document detailing the whole manufacturing process of Omarigliptin active pharmaceutical ingredient (API) in detail. Different forms of Omarigliptin DMFs exist exist since differing nations have different regulations, such as Omarigliptin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Omarigliptin DMF submitted to regulatory agencies in the US is known as a USDMF. Omarigliptin USDMF includes data on Omarigliptin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Omarigliptin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Omarigliptin suppliers with USDMF on PharmaCompass.
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