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 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.
A Docosanol DMF (Drug Master File) is a document detailing the whole manufacturing process of Docosanol active pharmaceutical ingredient (API) in detail. Different forms of Docosanol DMFs exist exist since differing nations have different regulations, such as Docosanol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Docosanol DMF submitted to regulatory agencies in the US is known as a USDMF. Docosanol USDMF includes data on Docosanol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Docosanol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Docosanol suppliers with USDMF on PharmaCompass.
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