Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Asymchem Laboratories
03 1Dipharma
04 1Dipharma SA
05 1HONOUR LAB LTD
06 1Hetero Drugs
07 1Innopharmax
08 1Maithri Drugs
09 1Mehta API
10 1Seven Star Pharmaceutical
11 1Shiratori Pharmaceutical
12 1Solara Active Pharma Sciences
01 1China
02 6India
03 1Italy
04 1Japan
05 1Switzerland
06 2Taiwan
01 7Active
02 1Inactive
03 4Blank
01 12Blank
01 12Blank
01 12Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-18
Pay. Date : 2021-09-28
DMF Number : 36147
Submission : 2021-07-31
Status : Active
Type : II
NDC Package Code : 73435-017
Start Marketing Date : 2021-12-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-03-13
Pay. Date : 2019-12-13
DMF Number : 34185
Submission : 2019-10-03
Status : Active
Type : II
NDC Package Code : 72643-026
Start Marketing Date : 2021-09-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-20
Pay. Date : 2019-07-26
DMF Number : 33928
Submission : 2019-08-06
Status : Active
Type : II
NDC Package Code : 69037-0048
Start Marketing Date : 2013-12-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28416
Submission : 2014-06-20
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-06-23
Pay. Date : 2019-03-22
DMF Number : 33553
Submission : 2019-02-19
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-08-26
Pay. Date : 2020-06-15
DMF Number : 34926
Submission : 2020-06-17
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-04
Pay. Date : 2013-09-23
DMF Number : 26682
Submission : 2012-12-06
Status : Active
Type : II
NDC Package Code : 46438-0660
Start Marketing Date : 2020-12-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17569
Submission : 2004-07-20
Status : Inactive
Type : II
NDC Package Code : 66652-2103
Start Marketing Date : 2019-01-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Sapropterin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sapropterin, including repackagers and relabelers. The FDA regulates Sapropterin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sapropterin 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 Sapropterin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sapropterin supplier is an individual or a company that provides Sapropterin active pharmaceutical ingredient (API) or Sapropterin finished formulations upon request. The Sapropterin suppliers may include Sapropterin API manufacturers, exporters, distributors and traders.
click here to find a list of Sapropterin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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