Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1USV Private Limited
03 1BASF
04 1BASF Corp
05 1ChemPacific Corp
06 3Chongqing Huapont Pharmaceutical
07 1GLOPEC INTERNATIONAL INC
08 1Hangzhou Deli Chemical
09 2Olon S.p.A
10 1RANBAXY LABORATORIES LIMITED
11 1Sionc Pharmaceuticals
12 1Solara Active Pharma Sciences
13 1Sun Pharmaceutical Industries Limited
01 1Canada
02 4China
03 1Germany
04 6India
05 2Italy
06 1U.S.A
07 1Blank
01 8Active
02 2Inactive
03 6Blank
01 4Valid
02 2Withdrawn by Holder
03 10Blank
01 16Blank
01 1WC-0012
02 1WC-0159
03 1WC-0273
04 13Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23310
Submission : 2009-12-10
Status : Active
Type : II
Certificate Number : CEP 2022-387 - Rev 00
Issue Date : 2024-10-24
Type : Chemical
Substance Number : 1385
Status : Valid
Date of Issue : 2022-06-27
Valid Till : 2025-06-02
Written Confirmation Number : WC-0012
Address of the Firm :
NDC Package Code : 62147-0145
Start Marketing Date : 2009-11-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-24
Pay. Date : 2017-03-14
DMF Number : 17001
Submission : 2003-12-01
Status : Active
Type : II
Certificate Number : R1-CEP 2005-186 - Rev 08
Issue Date : 2023-05-25
Type : Chemical
Substance Number : 1385
Status : Valid
NDC Package Code : 17337-0003
Start Marketing Date : 2012-12-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-10
Pay. Date : 2016-07-01
DMF Number : 24430
Submission : 2010-11-11
Status : Active
Type : II
NDC Package Code : 17337-0003
Start Marketing Date : 2012-12-03
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 : 22358
Submission : 2008-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24621
Submission : 2011-02-08
Status : Active
Type : II
Certificate Number : R0-CEP 2021-012 - Rev 00
Issue Date : 2022-11-30
Type : Chemical
Substance Number : 1385
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-04-13
Pay. Date : 2015-04-01
DMF Number : 26182
Submission : 2012-07-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21373
Submission : 2008-02-25
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-07
Pay. Date : 2014-12-11
DMF Number : 28896
Submission : 2014-12-22
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-25
Written Confirmation Number : WC-0159
Address of the Firm :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22090
Submission : 2008-10-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16580
Submission : 2003-05-12
Status : Inactive
Type : II
Date of Issue : 2020-07-23
Valid Till : 2023-05-11
Written Confirmation Number : WC-0273
Address of the Firm :
NDC Package Code : 76055-0001
Start Marketing Date : 2019-12-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2007-201 - Rev 00
Issue Date : 2013-11-15
Type : Chemical
Substance Number : 1385
Status : Withdrawn by Holder
Certificate Number : R1-CEP 2010-038 - Rev 02
Issue Date : 2018-08-17
Type : Chemical
Substance Number : 1385
Status : Valid
Certificate Number : R0-CEP 2005-226 - Rev 00
Issue Date : 2008-02-27
Type : Chemical
Substance Number : 1385
Status : Withdrawn by Holder
A Acitretin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acitretin, including repackagers and relabelers. The FDA regulates Acitretin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acitretin 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 Acitretin supplier is an individual or a company that provides Acitretin active pharmaceutical ingredient (API) or Acitretin finished formulations upon request. The Acitretin suppliers may include Acitretin API manufacturers, exporters, distributors and traders.
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