Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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01 1Nuray Chemicals Private Limited
02 1Omgene Life Sciences Pvt. Ltd
03 1Honour Lab Limited
04 1Anhui Biochem Pharmaceutical
05 1Apicore
06 1Arene Lifesciences
07 1Aurore Life Sciences
08 1Beijing Fukangren Biopharmaceutical
09 1DEAFARMA
10 2Dishman Carbogen Amcis
11 1Epoch Labs
12 1Hema Pharma
13 1MSN Laboratories
14 1Macleods Pharmaceuticals Limited
15 1Mana Pharma Ltd
16 1Micro Labs Limited
17 1Natco Pharma
18 1SMS Pharmaceuticals
19 1Shanvr Life Sciences
20 1Suzhou Biosyntech
21 1Viatris
22 1Zhejiang Hisun Chemical Co., Ltd.
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01 4China
02 17India
03 1Italy
04 1U.S.A
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01 2Active
02 21Blank
01 23Blank
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01 23Blank
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01 2WC-0135
02 1WC-0383
03 20Blank
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01 23Blank
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01 169766-058
02 22Blank
01 23Blank
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.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33268
Submission : 2018-10-30
Status : Active
Type : II
Date of Issue : 2025-09-24
Valid Till : 2028-08-08
Written Confirmation Number : WC-0383
Address of the Firm :
NDC Package Code : 69766-058
Start Marketing Date : 2018-10-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35426
Submission : 2020-12-14
Status : Active
Type : II






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PharmaCompass offers a list of Bedaquiline API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Bedaquiline manufacturer or Bedaquiline supplier for your needs.
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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.
click here to find a list of Bedaquiline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
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, and COA related information on PharmaCompass.
We have 22 companies offering Bedaquiline
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