01 1Arene Lifesciences
02 1Cipla
03 1Hetero Drugs
04 1Laurus Labs
05 1Lupin Ltd
06 1MSN Laboratories
07 1Mangalam Drugs & Organics Ltd
08 1Viatris
09 1Zhejiang Tianyu Pharmaceutical Co., Ltd
01 1China
02 7India
03 1U.S.A
01 6Active
02 3Blank
01 9Blank
01 9Blank
01 1WC-0213
02 8Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2022-01-26
Pay. Date : 2021-11-24
DMF Number : 36444
Submission : 2021-12-24
Status : Active
Type : II
Date of Issue : 2023-07-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0213
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-06
Pay. Date : 2021-05-28
DMF Number : 35866
Submission : 2021-05-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35655
Submission : 2021-02-27
Status : Active
Type : II
NDC Package Code : 69766-097
Start Marketing Date : 2021-02-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37428
Submission : 2022-09-16
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-05-26
Pay. Date : 2021-04-28
DMF Number : 35795
Submission : 2021-04-09
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-26
Pay. Date : 2019-06-06
DMF Number : 33906
Submission : 2019-07-17
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.
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