01 1ICURE PHARM, INC
01 1SURFADONE LP300
01 1South Korea
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32719
Submission : 2018-04-02
Status : Active
Type : II
A Surfadone LP-300 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Surfadone LP-300, including repackagers and relabelers. The FDA regulates Surfadone LP-300 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Surfadone LP-300 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 Surfadone LP-300 supplier is an individual or a company that provides Surfadone LP-300 active pharmaceutical ingredient (API) or Surfadone LP-300 finished formulations upon request. The Surfadone LP-300 suppliers may include Surfadone LP-300 API manufacturers, exporters, distributors and traders.
click here to find a list of Surfadone LP-300 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Surfadone LP-300 DMF (Drug Master File) is a document detailing the whole manufacturing process of Surfadone LP-300 active pharmaceutical ingredient (API) in detail. Different forms of Surfadone LP-300 DMFs exist exist since differing nations have different regulations, such as Surfadone LP-300 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Surfadone LP-300 DMF submitted to regulatory agencies in the US is known as a USDMF. Surfadone LP-300 USDMF includes data on Surfadone LP-300's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Surfadone LP-300 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Surfadone LP-300 suppliers with USDMF on PharmaCompass.
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