01 1M/s Emcure Pharmaceuticals Ltd
02 1M/s MSN Laboratories Private Limited
03 1M/s Sionc Phamaceuticals Pvt Ltd
04 1Solara Active Pharma Sciences Limited
01 4Zileuton USP
01 1WC-0021n
02 1WC-0127
03 1WC-0226
04 1WC-0273
01 4India
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm : D-24 and D24/1 MIDC Kurkumbh Tal. Daund, Dist Pune 413 802, Maharashtra State
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm : Sy. Nos: 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Man...
Date of Issue : 2020-07-23
Valid Till : 2023-05-11
Written Confirmation Number : WC-0273
Address of the Firm : Plot No. 34A, J.N.Pharma City, Thanam (V), Parawada (M), Vishakhapatnam-District...
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm : A1/B, SIPCOT Industrial Complex, Kudikadu, Cuddalore-607 005
A Zileuton manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zileuton, including repackagers and relabelers. The FDA regulates Zileuton manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zileuton 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 Zileuton manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zileuton supplier is an individual or a company that provides Zileuton active pharmaceutical ingredient (API) or Zileuton finished formulations upon request. The Zileuton suppliers may include Zileuton API manufacturers, exporters, distributors and traders.
click here to find a list of Zileuton suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zileuton written confirmation (Zileuton WC) is an official document issued by a regulatory agency to a Zileuton manufacturer, verifying that the manufacturing facility of a Zileuton active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zileuton APIs or Zileuton finished pharmaceutical products to another nation, regulatory agencies frequently require a Zileuton WC (written confirmation) as part of the regulatory process.
click here to find a list of Zileuton suppliers with Written Confirmation (WC) on PharmaCompass.
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