01 1S D Fine Chem Limited
02 1VIPOR CHEMICALS PRIVATE LTD
01 2CALAMINE BP
01 2India
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28683
Submission : 2014-09-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23022
Submission : 2009-05-20
Status : Inactive
Type : II
A Calamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calamine, including repackagers and relabelers. The FDA regulates Calamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calamine 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 Calamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calamine supplier is an individual or a company that provides Calamine active pharmaceutical ingredient (API) or Calamine finished formulations upon request. The Calamine suppliers may include Calamine API manufacturers, exporters, distributors and traders.
click here to find a list of Calamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Calamine active pharmaceutical ingredient (API) in detail. Different forms of Calamine DMFs exist exist since differing nations have different regulations, such as Calamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calamine DMF submitted to regulatory agencies in the US is known as a USDMF. Calamine USDMF includes data on Calamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calamine suppliers with USDMF on PharmaCompass.
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