01 1ALP Pharm
01 1ROSMARINIC ACID (DRUG SUBSTANCE, NON-STERILE)
01 1China
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22168
Submission : 2008-10-27
Status : Inactive
Type : II
A Rosmarinic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rosmarinic Acid, including repackagers and relabelers. The FDA regulates Rosmarinic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rosmarinic Acid 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 Rosmarinic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rosmarinic Acid supplier is an individual or a company that provides Rosmarinic Acid active pharmaceutical ingredient (API) or Rosmarinic Acid finished formulations upon request. The Rosmarinic Acid suppliers may include Rosmarinic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Rosmarinic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rosmarinic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Rosmarinic Acid active pharmaceutical ingredient (API) in detail. Different forms of Rosmarinic Acid DMFs exist exist since differing nations have different regulations, such as Rosmarinic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rosmarinic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Rosmarinic Acid USDMF includes data on Rosmarinic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rosmarinic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rosmarinic Acid suppliers with USDMF on PharmaCompass.
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