01 1Archimica
01 1SANCYCLINE
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11842
Submission : 1996-01-26
Status : Inactive
Type : II
A Sancycline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sancycline, including repackagers and relabelers. The FDA regulates Sancycline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sancycline 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 Sancycline supplier is an individual or a company that provides Sancycline active pharmaceutical ingredient (API) or Sancycline finished formulations upon request. The Sancycline suppliers may include Sancycline API manufacturers, exporters, distributors and traders.
click here to find a list of Sancycline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sancycline DMF (Drug Master File) is a document detailing the whole manufacturing process of Sancycline active pharmaceutical ingredient (API) in detail. Different forms of Sancycline DMFs exist exist since differing nations have different regulations, such as Sancycline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sancycline DMF submitted to regulatory agencies in the US is known as a USDMF. Sancycline USDMF includes data on Sancycline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sancycline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sancycline suppliers with USDMF on PharmaCompass.
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