01 1Anhui Huaxin Biotech
02 1Ruchi Menthol Pvt Ltd
01 1MENTHOL
02 1MENTHOL USP/BP/EP/IP
01 1China
02 1India
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36246
Submission : 2022-01-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33583
Submission : 2019-02-19
Status : Active
Type : II
A Menthol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Menthol, including repackagers and relabelers. The FDA regulates Menthol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Menthol 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 Menthol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Menthol supplier is an individual or a company that provides Menthol active pharmaceutical ingredient (API) or Menthol finished formulations upon request. The Menthol suppliers may include Menthol API manufacturers, exporters, distributors and traders.
click here to find a list of Menthol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Menthol DMF (Drug Master File) is a document detailing the whole manufacturing process of Menthol active pharmaceutical ingredient (API) in detail. Different forms of Menthol DMFs exist exist since differing nations have different regulations, such as Menthol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Menthol DMF submitted to regulatory agencies in the US is known as a USDMF. Menthol USDMF includes data on Menthol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Menthol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Menthol suppliers with USDMF on PharmaCompass.
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