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KUALA LUMPUR, 9 Jan 2017:
Pharmaceutical company Hovid Bhd announced its manufacturing licences have been revoked by the Ministry of Health today due to compliance issue.
The company said it received a letter informing it of the revocation from the Pharmaceutical Services Division (PSD) of the ministry via facsimile (fax) today.
“Consequently, all our manufacturing activities are halted with immediate effect today,” it said in a filing to Bursa Malaysia.
Hovid has two manufacturing facilities and both their manufacturing licences have been revoked.
The action from PSD arises from the audit conducted by the National Pharmaceutical Regulatory Department (NPRA) on Jan 5 this year.
The revocation was based on the audit findings that the current Good Manufacturing Practice (cGMP) compliance are not acceptable, and the Pharmaceutical Quality System does not comply with the latest cGMP requirements.
“Hovid targets to revert with the necessary corrective actions to comply with cGMP required by NPRA by the end of January 2017, and will invite the NPRA to audit our facilities and cGMP immediately thereafter.”
The reissuance of the licences would be subject to NPRA being satisfied with the outcome of their audit, it said.
However, the distribution subsidiaries in Malaysia, Hong Kong and the Philippines would continue to market and sell the existing stocks held by them respectively, said Hovid.
Last week, NPRA ordered Hovid to withdraw batch BG04645 Ternolol 50 film-coated tablets.
The agency said patients should return the medicine to clinics, pharmacies or health clinics and ask for advice from medical practitioners and undergo examination if necessary.