IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
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04 2Adare Pharma Solutions
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24 2Shandong Xinhua Pharmaceutical
25 4Solara Active Pharma Sciences
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28 1Zambon Switzerland
29 1Zibo Xinhua Perrigo Pharmaceutical
30 13Blank
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-13
Pay. Date : 2014-06-09
DMF Number : 22431
Submission : 2009-01-15
Status :
Type : II
A Alaxan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alaxan, including repackagers and relabelers. The FDA regulates Alaxan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alaxan 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 Alaxan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alaxan supplier is an individual or a company that provides Alaxan active pharmaceutical ingredient (API) or Alaxan finished formulations upon request. The Alaxan suppliers may include Alaxan API manufacturers, exporters, distributors and traders.
click here to find a list of Alaxan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alaxan DMF (Drug Master File) is a document detailing the whole manufacturing process of Alaxan active pharmaceutical ingredient (API) in detail. Different forms of Alaxan DMFs exist exist since differing nations have different regulations, such as Alaxan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alaxan DMF submitted to regulatory agencies in the US is known as a USDMF. Alaxan USDMF includes data on Alaxan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alaxan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alaxan suppliers with USDMF on PharmaCompass.
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