01 1Cipla
02 1Hetero Drugs
03 1Laurus Labs
04 1Lupin Ltd
05 1MSN Laboratories
06 1Viatris
01 5BICTEGRAVIR SODIUM
02 1BICTEGRAVIR SODIUM (MICRONIZED)
01 5India
02 1U.S.A
01 6Active
01 4Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-06
Pay. Date : 2021-05-28
DMF Number : 35866
Submission : 2021-05-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-26
Pay. Date : 2019-06-06
DMF Number : 33906
Submission : 2019-07-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-26
Pay. Date : 2021-11-24
DMF Number : 36444
Submission : 2021-12-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-26
Pay. Date : 2021-04-28
DMF Number : 35795
Submission : 2021-04-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35655
Submission : 2021-02-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37428
Submission : 2022-09-16
Status : Active
Type : II
A Bictegravir Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bictegravir Sodium, including repackagers and relabelers. The FDA regulates Bictegravir Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bictegravir Sodium 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 Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bictegravir Sodium supplier is an individual or a company that provides Bictegravir Sodium active pharmaceutical ingredient (API) or Bictegravir Sodium finished formulations upon request. The Bictegravir Sodium suppliers may include Bictegravir Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Bictegravir Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bictegravir Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Bictegravir Sodium active pharmaceutical ingredient (API) in detail. Different forms of Bictegravir Sodium DMFs exist exist since differing nations have different regulations, such as Bictegravir Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bictegravir Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Bictegravir Sodium USDMF includes data on Bictegravir Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bictegravir Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bictegravir Sodium suppliers with USDMF on PharmaCompass.
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