Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Actavis Inc
03 1Aurobindo Pharma Limited
04 1Macleods Pharmaceuticals Limited
05 1Maithri Drugs
06 1SASOL GERMANY GMBH
07 1Taro Pharmaceutical Industries
01 11-DOCOSANOL
02 11-DOCOSANOL (BEHENYL ALCOHOL)
03 5DOCOSANOL
01 1Germany
02 4India
03 1Ireland
04 1U.S.A
01 7Active
01 6Complete
02 1Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-05
Pay. Date : 2018-09-26
DMF Number : 33064
Submission : 2018-09-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-16
Pay. Date : 2015-06-08
DMF Number : 29410
Submission : 2015-06-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-15
Pay. Date : 2020-09-03
DMF Number : 35164
Submission : 2020-09-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-12
Pay. Date : 2023-12-27
DMF Number : 38621
Submission : 2023-12-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-27
Pay. Date : 2019-08-19
DMF Number : 33229
Submission : 2018-10-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9513
Submission : 1992-01-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-02
Pay. Date : 2019-03-07
DMF Number : 33165
Submission : 2019-03-18
Status : Active
Type : II
A Abreva manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Abreva, including repackagers and relabelers. The FDA regulates Abreva manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Abreva 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 Abreva manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Abreva supplier is an individual or a company that provides Abreva active pharmaceutical ingredient (API) or Abreva finished formulations upon request. The Abreva suppliers may include Abreva API manufacturers, exporters, distributors and traders.
click here to find a list of Abreva suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Abreva DMF (Drug Master File) is a document detailing the whole manufacturing process of Abreva active pharmaceutical ingredient (API) in detail. Different forms of Abreva DMFs exist exist since differing nations have different regulations, such as Abreva USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Abreva DMF submitted to regulatory agencies in the US is known as a USDMF. Abreva USDMF includes data on Abreva's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Abreva USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Abreva suppliers with USDMF on PharmaCompass.
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