01 1Chengdu Shengnuo Biopharm
01 1ZICONOTIDE ACETATE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-23
Pay. Date : 2019-06-18
DMF Number : 33139
Submission : 2019-04-11
Status : Active
Type : II
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PharmaCompass offers a list of Ziconotide Acetate 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 Ziconotide Acetate manufacturer or Ziconotide Acetate supplier for your needs.
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A Prialt manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prialt, including repackagers and relabelers. The FDA regulates Prialt manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prialt 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 Prialt manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Prialt supplier is an individual or a company that provides Prialt active pharmaceutical ingredient (API) or Prialt finished formulations upon request. The Prialt suppliers may include Prialt API manufacturers, exporters, distributors and traders.
click here to find a list of Prialt suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Prialt DMF (Drug Master File) is a document detailing the whole manufacturing process of Prialt active pharmaceutical ingredient (API) in detail. Different forms of Prialt DMFs exist exist since differing nations have different regulations, such as Prialt USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prialt DMF submitted to regulatory agencies in the US is known as a USDMF. Prialt USDMF includes data on Prialt's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prialt USDMF is kept confidential to protect the manufacturer’s intellectual property.
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