Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1HRV Global Life Sciences
03 1TAPI Technology & API Services
04 1Actavis Inc
05 1Aurobindo Pharma Limited
06 2Azico Biophore India Pvt. Ltd
07 1Macleods Pharmaceuticals Limited
08 2Maithri Drugs
09 1SASOL GERMANY GMBH
10 1SKVen Technologies Pvt. Ltd
11 1Taro Pharmaceutical Industries
01 1Germany
02 9India
03 1Ireland
04 1Israel
05 1U.S.A
01 7Active
02 6Blank
01 13Blank
01 13Blank
01 1WC-0002A2
02 1WC-0199A1
03 1WC-0404
04 1WC-0404A2
05 1WC-0407
06 1WC-0407A6
07 7Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-11-05
Pay. Date : 2018-09-26
DMF Number : 33064
Submission : 2018-09-07
Status : Active
Type : II
Date of Issue : 2022-05-26
Valid Till : 2025-05-25
Written Confirmation Number : WC-0002A2
Address of the Firm :
NDC Package Code : 15894-0036
Start Marketing Date : 2020-10-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-10-15
Pay. Date : 2020-09-03
DMF Number : 35164
Submission : 2020-09-04
Status : Active
Type : II
NDC Package Code : 59651-490
Start Marketing Date : 2024-01-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-07-02
Pay. Date : 2019-03-07
DMF Number : 33165
Submission : 2019-03-18
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-12
Pay. Date : 2023-12-27
DMF Number : 38621
Submission : 2023-12-20
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-16
Pay. Date : 2015-06-08
DMF Number : 29410
Submission : 2015-06-19
Status : Active
Type : II
Date of Issue : 2021-07-29
Valid Till : 2022-08-15
Written Confirmation Number : WC-0199A1
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9513
Submission : 1992-01-17
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-27
Pay. Date : 2019-08-19
DMF Number : 33229
Submission : 2018-10-17
Status : Active
Type : II
Date of Issue : 2020-09-09
Valid Till : 2023-06-28
Written Confirmation Number : WC-0407
Address of the Firm :
Date of Issue : 2020-08-17
Valid Till : 2023-06-22
Written Confirmation Number : WC-0404
Address of the Firm :
NDC Package Code : 69575-4024
Start Marketing Date : 2017-12-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
A Docosanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Docosanol, including repackagers and relabelers. The FDA regulates Docosanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Docosanol 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 Docosanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Docosanol supplier is an individual or a company that provides Docosanol active pharmaceutical ingredient (API) or Docosanol finished formulations upon request. The Docosanol suppliers may include Docosanol API manufacturers, exporters, distributors and traders.
click here to find a list of Docosanol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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