01 1Chemi SpA
01 1AICA HYDROCHLORIDE
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14013
Submission : 1999-03-05
Status : Active
Type : II
94
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A 08220_FLUKA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 08220_FLUKA, including repackagers and relabelers. The FDA regulates 08220_FLUKA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 08220_FLUKA API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A 08220_FLUKA supplier is an individual or a company that provides 08220_FLUKA active pharmaceutical ingredient (API) or 08220_FLUKA finished formulations upon request. The 08220_FLUKA suppliers may include 08220_FLUKA API manufacturers, exporters, distributors and traders.
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A 08220_FLUKA DMF (Drug Master File) is a document detailing the whole manufacturing process of 08220_FLUKA active pharmaceutical ingredient (API) in detail. Different forms of 08220_FLUKA DMFs exist exist since differing nations have different regulations, such as 08220_FLUKA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 08220_FLUKA DMF submitted to regulatory agencies in the US is known as a USDMF. 08220_FLUKA USDMF includes data on 08220_FLUKA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 08220_FLUKA USDMF is kept confidential to protect the manufacturer’s intellectual property.
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