Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Emcure Pharmaceuticals
03 1MSN Laboratories
04 1Shenzhen JYMed Technology
01 1China
02 3India
01 1Active
02 3Blank
01 4Blank
01 4Blank
01 1WC-0383
02 1WC-0587
03 2Blank
01 4Blank
01 169766-100
02 3Blank
01 4Blank
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 : 35777
Submission : 2021-06-03
Status : Active
Type : II
Date of Issue : 2022-08-08
Valid Till : 2025-08-08
Written Confirmation Number : WC-0383
Address of the Firm :
NDC Package Code : 69766-100
Start Marketing Date : 2021-06-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2024-07-31
Valid Till : 2027-07-30
Written Confirmation Number : WC-0587
Address of the Firm :
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A RLF-100 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of RLF-100, including repackagers and relabelers. The FDA regulates RLF-100 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. RLF-100 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 RLF-100 supplier is an individual or a company that provides RLF-100 active pharmaceutical ingredient (API) or RLF-100 finished formulations upon request. The RLF-100 suppliers may include RLF-100 API manufacturers, exporters, distributors and traders.
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