01 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
01 12,5-PYRIDINEDICARBOXYLIC ACID,1-(2,2-DIMETHOXYETHYL)-1,4-DIHYDRO-3-METHOXY-4-OXO-, 2-METHYL ESTER
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34984
Submission : 2020-06-28
Status : Active
Type : II
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PharmaCompass offers a list of Bictegravir API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Bictegravir manufacturer or Bictegravir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bictegravir manufacturer or Bictegravir supplier.
PharmaCompass also assists you with knowing the Bictegravir API Price utilized in the formulation of products. Bictegravir API Price is not always fixed or binding as the Bictegravir Price is obtained through a variety of data sources. The Bictegravir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bictegravir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bictegravir, including repackagers and relabelers. The FDA regulates Bictegravir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bictegravir 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 Bictegravir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bictegravir supplier is an individual or a company that provides Bictegravir active pharmaceutical ingredient (API) or Bictegravir finished formulations upon request. The Bictegravir suppliers may include Bictegravir API manufacturers, exporters, distributors and traders.
click here to find a list of Bictegravir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bictegravir DMF (Drug Master File) is a document detailing the whole manufacturing process of Bictegravir active pharmaceutical ingredient (API) in detail. Different forms of Bictegravir DMFs exist exist since differing nations have different regulations, such as Bictegravir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bictegravir DMF submitted to regulatory agencies in the US is known as a USDMF. Bictegravir USDMF includes data on Bictegravir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bictegravir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bictegravir suppliers with USDMF on PharmaCompass.
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