
The company said it received a letter informing it of the revocation from the Pharmaceutical Services Division (PSD) of the ministry via facsimile today.
“Consequently, all our manufacturing activities are halted with immediate effect today (yesterday),” 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Hovid has two manufacturing facilities and both their manufacturing licences have been revoked.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, 2017.
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 re-issuance 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.
Following this, Hovid announced a recall for Ternolol 50mg film-coated tablets manufactured under batch number BG04645 bearing manufacturing date April 2016 for the Malaysian market.
It explained that the batch for recall contained boxes labelled as “Ternolol 50”, however, some of the blisters stated the product as “Ternolol Tab 100mg”.
The pharmaceutical company said the actual product packed in the boxes was Ternolol 50mg which corresponded with the box label.