9 Atozet generic companies to join CKD via consignment
By Lee, Tak-Sun | translator Byun Kyung A
21.01.11 12:20:51
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9 out of 26 approved to conduct bioequivalence test settled on consignment contract with CKD
Highly likely to receive reimbursed pricing in April, Atozet market to face a major change in dynamic
▲A dyslipidemia treating combination drug ‘Atozet’ by MSD
Nine pharmaceutical companies, initially preparing to launch a generic version of a dyslipidemia treatment Atozet (atorvastatin plus ezetimibe), joined a group of manufacturers to produce Chong Kun Dang’s evidence-submitting drug as CMO. Instead of generics applying for the health authority approval from this month, the companies seem to have chosen to manufacture the follow-on drug with evidence submission under the consignment contract. Apparently, some of them have already completed the bioequivalence test successfully.
On Jan. 8, South Korea’s Ministry of Food and Drug Safety (MFDS) granted approval on 22 companies’ atorvastatin calcium plus ezetimibe combination drugs. Some of
Lee, Tak-Sun(hooggasi2@dailypharm.com)
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