01 2Chromo Laboratories
02 1Hetero Drugs
01 1ZAFIRLUKAST
02 1ZAFIRLUKAST (AMORPHOUS)
03 1ZAFIRLUKAST PREMIX-50% W/W
01 3India
01 3Active
01 2Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-20
Pay. Date : 2018-12-18
DMF Number : 26359
Submission : 2012-09-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31869
Submission : 2017-08-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-13
Pay. Date : 2018-01-11
DMF Number : 32415
Submission : 2018-02-12
Status : Active
Type : II
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PharmaCompass offers a list of Zafirlukast 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 Zafirlukast manufacturer or Zafirlukast supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Zafirlukast manufacturer or Zafirlukast supplier.
A Zafirlukast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zafirlukast, including repackagers and relabelers. The FDA regulates Zafirlukast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zafirlukast 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 Zafirlukast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Zafirlukast supplier is an individual or a company that provides Zafirlukast active pharmaceutical ingredient (API) or Zafirlukast finished formulations upon request. The Zafirlukast suppliers may include Zafirlukast API manufacturers, exporters, distributors and traders.
click here to find a list of Zafirlukast suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Zafirlukast DMF (Drug Master File) is a document detailing the whole manufacturing process of Zafirlukast active pharmaceutical ingredient (API) in detail. Different forms of Zafirlukast DMFs exist exist since differing nations have different regulations, such as Zafirlukast USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zafirlukast DMF submitted to regulatory agencies in the US is known as a USDMF. Zafirlukast USDMF includes data on Zafirlukast's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zafirlukast USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zafirlukast suppliers with USDMF on PharmaCompass.
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