Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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01 2Biophore India Pharmaceuticals Pvt Ltd
02 1Egis Pharmaceuticals PLC
03 1Neuland Laboratories
04 1Apicore
05 1Emcure Pharmaceuticals
06 3Enaltec Labs Private Limited
07 1Laboratorio Chimico Internazionale Spa
08 2Olon S.p.A
09 1Sai Life Sciences Limited
10 2Sionc Pharmaceuticals
11 1Solara Active Pharma Sciences
12 1Sunny Pharmtech
13 1TopChem Pharmaceuticals
14 1Viatris
15 1Zydus Lifesciences
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01 1Hungary
02 13India
03 1Ireland
04 3Italy
05 1Taiwan
06 1U.S.A
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01 11Active
02 1Inactive
03 8Blank
01 2Valid
02 18Blank
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01 20Blank
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01 1WC-0037
02 1WC-0126-Amended
03 1WC-0226
04 1WC-0273
05 1WC-0424
06 15Blank
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01 20Blank
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01 117337-0401
02 117337-0429
03 142413-0059
04 142973-169
05 148581-320
06 165841-175
07 176055-0022
08 13Blank
01 20Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-17
Pay. Date : 2015-09-08
DMF Number : 29429
Submission : 2015-06-06
Status : Active
Type : II
Certificate Number : CEP 2018-288 - Rev 01
Issue Date : 2025-02-19
Type : Chemical
Substance Number : 457
Status : Valid
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17193
Submission : 2004-02-26
Status : Active
Type : II
Certificate Number : R1-CEP 2004-053 - Rev 01
Issue Date : 2019-04-16
Type : Chemical
Substance Number : 457
Status : Valid
NDC Package Code : 48581-320
Start Marketing Date : 2020-04-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-15
Pay. Date : 2013-09-20
DMF Number : 27473
Submission : 2013-09-03
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
Address of the Firm :
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-23
Pay. Date : 2016-09-21
DMF Number : 30813
Submission : 2016-09-19
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-31
Pay. Date : 2018-09-27
DMF Number : 32069
Submission : 2017-09-28
Status : Active
Type : II
Date of Issue : 2022-07-15
Valid Till : 2025-07-25
Written Confirmation Number : WC-0126-Amended
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-11-21
Pay. Date : 2017-10-18
DMF Number : 31925
Submission : 2017-10-23
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-25
Pay. Date : 2014-07-15
DMF Number : 25936
Submission : 2012-05-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-16
Pay. Date : 2013-05-03
DMF Number : 26013
Submission : 2012-06-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-31
Pay. Date : 2013-05-16
DMF Number : 25973
Submission : 2012-04-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31600
Submission : 2017-04-26
Status : Inactive
Type : II
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