Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1HRV Global Life Sciences
03 1ALP Pharm
04 1ATON PHARMA INC
05 1Apicore LLC
06 1Apothecon Pharmaceuticals
07 1Aurobindo Pharma Limited
08 1Fleming Laboratories
09 1JIANGXI DONGFENG PHARMACEUTICAL LLC
10 2LABORCHEMIE APOLDA GMBH
11 1MSN Laboratories
12 1Optimus Pharma
13 1Prajna Generics
14 1RR LIFESCIENCES
15 1SAFC
16 1SIGMA TAU
17 1Sionc Pharmaceuticals
18 1Suven Life Sciences Limited
19 1Vijayasri Organics Limited
20 1Wanbury Limited
21 3Blank
01 2China
02 2Germany
03 14India
04 3U.S.A
05 3Blank
01 10Active
02 7Inactive
03 7Blank
01 2Valid
02 22Blank
01 24Blank
01 1WC-0042
02 1WC-0182
03 1WC-0273
04 21Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-01-13
Pay. Date : 2016-09-28
DMF Number : 30833
Submission : 2016-09-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-08-30
Pay. Date : 2018-01-19
DMF Number : 32411
Submission : 2018-07-27
Status : Active
Type : II
Date of Issue : 2022-11-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0182
Address of the Firm :
NDC Package Code : 59285-014
Start Marketing Date : 2017-10-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-09-28
Pay. Date : 2017-08-08
DMF Number : 31932
Submission : 2017-08-02
Status : Active
Type : II
NDC Package Code : 70159-004
Start Marketing Date : 2017-09-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-01-19
Pay. Date : 2016-09-28
DMF Number : 30993
Submission : 2016-10-18
Status : Active
Type : II
NDC Package Code : 42973-230
Start Marketing Date : 2016-07-30
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 : 26681
Submission : 2012-11-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27935
Submission : 2014-06-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24013
Submission : 2010-07-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-11-16
Pay. Date : 2018-09-27
DMF Number : 33106
Submission : 2018-09-28
Status : Active
Type : II
NDC Package Code : 76339-159
Start Marketing Date : 2019-09-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (9.999kg/9.999kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34461
Submission : 2019-12-31
Status : Active
Type : II
Certificate Number : R0-CEP 2020-240 - Rev 00
Issue Date : 2022-11-14
Type : Chemical
Substance Number : 566
Status : Valid
NDC Package Code : 72640-012
Start Marketing Date : 2019-12-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-12-29
Pay. Date : 2018-09-27
DMF Number : 33200
Submission : 2018-09-28
Status : Active
Type : II
NDC Package Code : 59651-245
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23156
Submission : 2009-09-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7690
Submission : 1988-09-21
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5413
Submission : 1984-05-09
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5521
Submission : 1984-08-16
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13601
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5868
Submission : 1985-06-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24701
Submission : 2011-03-01
Status : Inactive
Type : II
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0042
Address of the Firm :
Date of Issue : 2020-07-23
Valid Till : 2023-05-11
Written Confirmation Number : WC-0273
Address of the Firm :
NDC Package Code : 76055-0028
Start Marketing Date : 2019-12-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : CEP 2022-136 - Rev 00
Issue Date : 2024-06-17
Type : Chemical
Substance Number : 566
Status : Valid
NDC Package Code : 80151-002
Start Marketing Date : 2021-01-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
A Penicillamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Penicillamine, including repackagers and relabelers. The FDA regulates Penicillamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Penicillamine 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 Penicillamine supplier is an individual or a company that provides Penicillamine active pharmaceutical ingredient (API) or Penicillamine finished formulations upon request. The Penicillamine suppliers may include Penicillamine API manufacturers, exporters, distributors and traders.
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