Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
01 1Sichuan Elixir Pharmaceuticals
02 1Shaanxi Dahe Pharmaceutical
03 1Sichuan Xieli Pharmaceutical
01 2CYTISINE
02 1CYTISINICLINE
01 3China
01 3Active
01 3Blank
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39649
Submission : 2024-03-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38934
Submission : 2023-10-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35908
Submission : 2021-05-06
Status : Active
Type : II
A Cytisine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cytisine, including repackagers and relabelers. The FDA regulates Cytisine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cytisine 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 Cytisine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cytisine supplier is an individual or a company that provides Cytisine active pharmaceutical ingredient (API) or Cytisine finished formulations upon request. The Cytisine suppliers may include Cytisine API manufacturers, exporters, distributors and traders.
click here to find a list of Cytisine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cytisine DMF (Drug Master File) is a document detailing the whole manufacturing process of Cytisine active pharmaceutical ingredient (API) in detail. Different forms of Cytisine DMFs exist exist since differing nations have different regulations, such as Cytisine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cytisine DMF submitted to regulatory agencies in the US is known as a USDMF. Cytisine USDMF includes data on Cytisine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cytisine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cytisine suppliers with USDMF on PharmaCompass.
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