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 1Albemarle Corporation
03 1Derivados Quimicos SAU
04 1Esteve Quimica
05 1FDC
06 1Gufic Biosciences
07 1Johnson & Johnson Innovative Medicine
08 1Napp Technologies
09 1Piramal Pharma Solutions
10 3Quimica Sintetica
11 1Recordati
12 1Sharon Bio-Medicine Limited
13 1UQUIFA
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-23
Pay. Date : 2023-05-26
DMF Number : 38417
Submission : 2023-07-15
Status :
Type : II
A Ketoconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketoconazole, including repackagers and relabelers. The FDA regulates Ketoconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketoconazole 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 Ketoconazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ketoconazole supplier is an individual or a company that provides Ketoconazole active pharmaceutical ingredient (API) or Ketoconazole finished formulations upon request. The Ketoconazole suppliers may include Ketoconazole API manufacturers, exporters, distributors and traders.
click here to find a list of Ketoconazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ketoconazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Ketoconazole active pharmaceutical ingredient (API) in detail. Different forms of Ketoconazole DMFs exist exist since differing nations have different regulations, such as Ketoconazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ketoconazole DMF submitted to regulatory agencies in the US is known as a USDMF. Ketoconazole USDMF includes data on Ketoconazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ketoconazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ketoconazole suppliers with USDMF on PharmaCompass.
We have 13 companies offering Ketoconazole
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