Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Guangzhou Topwork Chemical
03 1Kekule Pharma
04 1SGMR Pharmaceuticals
05 1Sionc Pharmaceuticals
01 1China
02 4India
01 1Active
02 4Blank
01 1Valid
02 4Blank
01 5Blank
01 1WC-0273
02 4Blank
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
Date of Issue : 2020-07-23
Valid Till : 2023-05-11
Written Confirmation Number : WC-0273
Address of the Firm :
NDC Package Code : 76055-0025
Start Marketing Date : 2019-12-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Leukeran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leukeran, including repackagers and relabelers. The FDA regulates Leukeran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leukeran 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 Leukeran supplier is an individual or a company that provides Leukeran active pharmaceutical ingredient (API) or Leukeran finished formulations upon request. The Leukeran suppliers may include Leukeran API manufacturers, exporters, distributors and traders.
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