Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
01 1Nuray Chemicals Private Limited
02 1Omgene Life Sciences Pvt. Ltd
03 1Beijing Mesochem Technology
04 1Arene Lifesciences
05 1Aurore Life Sciences
06 1Beijing Fukangren Biopharmaceutical
07 1DEAFARMA
08 1Epoch Labs
09 1Haoyuan Chemexpress Co.Ltd
10 1MSN Laboratories
11 1Micro Labs Limited
12 1Natco Pharma
13 1Shanvr Life Sciences
14 1Suzhou Biosyntech
15 1Viatris
01 4China
02 9India
03 1Italy
04 1U.S.A
01 2Active
02 13Blank
01 15Blank
01 15Blank
01 1WC-0383A6
02 14Blank
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35426
Submission : 2020-12-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33268
Submission : 2018-10-30
Status : Active
Type : II
Date of Issue : 2020-07-27
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A6
Address of the Firm :
NDC Package Code : 69766-058
Start Marketing Date : 2018-10-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Bedaquiline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bedaquiline, including repackagers and relabelers. The FDA regulates Bedaquiline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bedaquiline 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 Bedaquiline supplier is an individual or a company that provides Bedaquiline active pharmaceutical ingredient (API) or Bedaquiline finished formulations upon request. The Bedaquiline suppliers may include Bedaquiline API manufacturers, exporters, distributors and traders.
click here to find a list of Bedaquiline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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