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