Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
01 1Zhejiang Hengkang Pharmaceutical
02 1HRV Global Life Sciences
03 1Acura Labs
04 1Apotex Pharmachem
05 1Arene Lifesciences
06 2Hetero Drugs
07 1Johnson & Johnson Innovative Medicine
08 1MSN Laboratories
09 1Viatris
01 1Canada
02 1China
03 6India
04 2U.S.A
01 5Active
02 1Inactive
03 4Blank
01 10Blank
01 10Blank
01 1WC-0016
02 1WC-0041
03 1WC-0383A4
04 7Blank
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-07
Pay. Date : 2014-11-25
DMF Number : 28813
Submission : 2014-12-22
Status : Active
Type : II
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0016
Address of the Firm :
NDC Package Code : 65015-856
Start Marketing Date : 2015-03-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-22
Pay. Date : 2014-05-15
DMF Number : 25550
Submission : 2011-12-01
Status : Active
Type : II
Date of Issue : 2022-09-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0056
Start Marketing Date : 2008-01-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-20
Pay. Date : 2021-06-17
DMF Number : 35835
Submission : 2021-06-15
Status : Active
Type : II
NDC Package Code : 68554-0056
Start Marketing Date : 2008-01-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-02-13
Pay. Date : 2019-01-28
DMF Number : 29404
Submission : 2015-05-31
Status : Active
Type : II
Date of Issue : 2019-10-15
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A4
Address of the Firm :
NDC Package Code : 69766-001
Start Marketing Date : 2015-05-31
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 : 20440
Submission : 2007-04-18
Status : Active
Type : II
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2008-05-07
Registration Number : Su217-3-ND
Manufacturer Name : Janssen Pharmaceutica NV
Manufacturer Address : Janssen Pharmaceuticalaan 3B-2440 Geel, Belgium
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27923
Submission : 2014-03-07
Status : Inactive
Type : II
A Etravirine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Etravirine, including repackagers and relabelers. The FDA regulates Etravirine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Etravirine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Etravirine supplier is an individual or a company that provides Etravirine active pharmaceutical ingredient (API) or Etravirine finished formulations upon request. The Etravirine suppliers may include Etravirine API manufacturers, exporters, distributors and traders.
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