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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 31869
Submission : 2017-08-18
Status : Active
Type : II
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 : 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, Price,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.
PharmaCompass also assists you with knowing the Zafirlukast API Price utilized in the formulation of products. Zafirlukast API Price is not always fixed or binding as the Zafirlukast Price is obtained through a variety of data sources. The Zafirlukast Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Accolate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Accolate, including repackagers and relabelers. The FDA regulates Accolate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Accolate 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 Accolate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Accolate supplier is an individual or a company that provides Accolate active pharmaceutical ingredient (API) or Accolate finished formulations upon request. The Accolate suppliers may include Accolate API manufacturers, exporters, distributors and traders.
click here to find a list of Accolate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Accolate DMF (Drug Master File) is a document detailing the whole manufacturing process of Accolate active pharmaceutical ingredient (API) in detail. Different forms of Accolate DMFs exist exist since differing nations have different regulations, such as Accolate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Accolate DMF submitted to regulatory agencies in the US is known as a USDMF. Accolate USDMF includes data on Accolate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Accolate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Accolate suppliers with USDMF on PharmaCompass.
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