QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD
Overview
QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD is an active pharmaceutical ingredient (API) supplier with 8 active FDA Type II Drug Master Files, covering CHORIONIC GONADOTROPIN; DIENOGEST (MICRONIZED); ESTRONE; GESTODENE (MICRONIZED); LEVONORGESTREL (MICRONIZED); MENOTROPINS.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
QINHUANGDAO ZIZHU PHARMACEUTICAL CO LTD holds 6 active (6 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- GESTODENE (MICRONIZED)Active2015-06-08
- TIBOLONEActive2015-03-26
- DIENOGEST (MICRONIZED)Active2014-09-25
- ESTRONEActive2014-05-13
- LEVONORGESTREL (MICRONIZED)Active2013-10-20
- MIFEPRISTONEActive2011-01-30
FDA compliance signals
8 FDA enforcement records linked to this company.
- warning_letter2017-04-24
FDA Warning Letter (drug product)
- recall — Class II2017-04-19
cGMP Deviations; lack of quality assurance.
- recall — Class II2017-04-19
cGMP Deviations; lack of quality assurance.
- recall — Class II2017-04-19
cGMP Deviations; lack of quality assurance.
- recall — Class II2017-04-19
cGMP Deviations; lack of quality assurance.
- recall — Class II2017-04-19
cGMP Deviations; lack of quality assurance.
- recall — Class II2017-04-19
cGMP Deviations; lack of quality assurance.
- recall — Class II2017-04-19
cGMP Deviations; lack of quality assurance.
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