01 1Sichuan Xieli Pharmaceutical
01 1INGENOL MEBUTATE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-23
Pay. Date : 2015-08-12
DMF Number : 29556
Submission : 2015-07-17
Status : Active
Type : II
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PharmaCompass offers a list of Ingenol Mebutate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ingenol Mebutate manufacturer or Ingenol Mebutate supplier for your needs.
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A Ingenol Mebutate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ingenol Mebutate, including repackagers and relabelers. The FDA regulates Ingenol Mebutate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ingenol Mebutate 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 Ingenol Mebutate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ingenol Mebutate supplier is an individual or a company that provides Ingenol Mebutate active pharmaceutical ingredient (API) or Ingenol Mebutate finished formulations upon request. The Ingenol Mebutate suppliers may include Ingenol Mebutate API manufacturers, exporters, distributors and traders.
click here to find a list of Ingenol Mebutate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ingenol Mebutate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ingenol Mebutate active pharmaceutical ingredient (API) in detail. Different forms of Ingenol Mebutate DMFs exist exist since differing nations have different regulations, such as Ingenol Mebutate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ingenol Mebutate DMF submitted to regulatory agencies in the US is known as a USDMF. Ingenol Mebutate USDMF includes data on Ingenol Mebutate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ingenol Mebutate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ingenol Mebutate suppliers with USDMF on PharmaCompass.
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