01 1Cipla
01 1CABOTEGRAVIR
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37939
Submission : 2023-03-20
Status : Active
Type : II
A Cabotegravir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cabotegravir, including repackagers and relabelers. The FDA regulates Cabotegravir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cabotegravir 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 Cabotegravir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cabotegravir supplier is an individual or a company that provides Cabotegravir active pharmaceutical ingredient (API) or Cabotegravir finished formulations upon request. The Cabotegravir suppliers may include Cabotegravir API manufacturers, exporters, distributors and traders.
click here to find a list of Cabotegravir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cabotegravir DMF (Drug Master File) is a document detailing the whole manufacturing process of Cabotegravir active pharmaceutical ingredient (API) in detail. Different forms of Cabotegravir DMFs exist exist since differing nations have different regulations, such as Cabotegravir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cabotegravir DMF submitted to regulatory agencies in the US is known as a USDMF. Cabotegravir USDMF includes data on Cabotegravir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cabotegravir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cabotegravir suppliers with USDMF on PharmaCompass.
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