01 1Silverline Chemical
01 1CAMPHOR EP/BP/USP/JP
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35026
Submission : 2020-08-26
Status : Active
Type : IV
A Camphor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Camphor, including repackagers and relabelers. The FDA regulates Camphor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Camphor 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 Camphor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Camphor supplier is an individual or a company that provides Camphor active pharmaceutical ingredient (API) or Camphor finished formulations upon request. The Camphor suppliers may include Camphor API manufacturers, exporters, distributors and traders.
click here to find a list of Camphor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Camphor DMF (Drug Master File) is a document detailing the whole manufacturing process of Camphor active pharmaceutical ingredient (API) in detail. Different forms of Camphor DMFs exist exist since differing nations have different regulations, such as Camphor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Camphor DMF submitted to regulatory agencies in the US is known as a USDMF. Camphor USDMF includes data on Camphor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Camphor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Camphor suppliers with USDMF on PharmaCompass.
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