01 1NEOMPS INC
01 1ACYLINE
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12522
Submission : 1997-05-12
Status : Active
Type : II
A Acyline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acyline, including repackagers and relabelers. The FDA regulates Acyline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acyline 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 Acyline supplier is an individual or a company that provides Acyline active pharmaceutical ingredient (API) or Acyline finished formulations upon request. The Acyline suppliers may include Acyline API manufacturers, exporters, distributors and traders.
click here to find a list of Acyline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acyline DMF (Drug Master File) is a document detailing the whole manufacturing process of Acyline active pharmaceutical ingredient (API) in detail. Different forms of Acyline DMFs exist exist since differing nations have different regulations, such as Acyline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acyline DMF submitted to regulatory agencies in the US is known as a USDMF. Acyline USDMF includes data on Acyline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acyline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acyline suppliers with USDMF on PharmaCompass.
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