01 1ORGAMOL PHARMA SOLUTIONS SA
02 1Recordati
01 2MEBEVERINE HYDROCHLORIDE
01 1Italy
02 1Switzerland
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8042
Submission : 1989-04-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8297
Submission : 1989-11-13
Status : Inactive
Type : II
A Mebeverine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mebeverine, including repackagers and relabelers. The FDA regulates Mebeverine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mebeverine 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 Mebeverine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mebeverine supplier is an individual or a company that provides Mebeverine active pharmaceutical ingredient (API) or Mebeverine finished formulations upon request. The Mebeverine suppliers may include Mebeverine API manufacturers, exporters, distributors and traders.
click here to find a list of Mebeverine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mebeverine DMF (Drug Master File) is a document detailing the whole manufacturing process of Mebeverine active pharmaceutical ingredient (API) in detail. Different forms of Mebeverine DMFs exist exist since differing nations have different regulations, such as Mebeverine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mebeverine DMF submitted to regulatory agencies in the US is known as a USDMF. Mebeverine USDMF includes data on Mebeverine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mebeverine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mebeverine suppliers with USDMF on PharmaCompass.
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