Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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01 1Biophore India Pharmaceuticals Pvt Ltd
02 1American Pacific Corporation
03 1Darmerica
04 1Guangzhou Topwork Chemical
05 1Kekule Pharma
06 1SGMR Pharmaceuticals
07 1Sionc Pharmaceuticals
08 1Willow Birch Pharma
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01 1China
02 4India
03 3U.S.A
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01 1Active
02 7Blank
01 1Valid
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01 8Blank
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01 1WC-0273
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01 8Blank
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01 150683-0384
02 171052-212
03 176055-0025
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01 8Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-01
Pay. Date : 2015-09-09
DMF Number : 28956
Submission : 2015-05-25
Status : Active
Type : II
Certificate Number : CEP 2017-136 - Rev 01
Issue Date : 2024-02-22
Type : Chemical
Substance Number : 137
Status : Valid
NDC Package Code : 71052-212
Start Marketing Date : 2017-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

Date of Issue : 2023-11-15
Valid Till : 2026-05-11
Written Confirmation Number : WC-0273
Address of the Firm :
NDC Package Code : 76055-0025
Start Marketing Date : 2019-12-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT



NDC Package Code : 50683-0384
Start Marketing Date : 2001-05-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT



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A Celkeran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Celkeran, including repackagers and relabelers. The FDA regulates Celkeran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Celkeran 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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We have 8 companies offering Celkeran
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