LLOYD LABORATORIES, Inc. said it is awaiting approval from the Food and Drug Administration (FDA) to begin manufacturing Molnupiravir, an oral drug to treat coronavirus disease 2019 (COVID-19).
“Once cleared, within no time at all we can make the capsules available to people in the Philippines. We are ready for the manufacturing of the product immediately. If the FDA gives the clearance tomorrow, from five to seven days we can make it available to the market,” Vice-President for Research and Development Chandra Shekhara Reddy Nagareddy said in a briefing on Thursday.
On Monday, the Board of Investments approved the application lodged by Lloyd Laboratories to register the drug manufacturing operation for incentives.
The pharmaceutical company said it submitted all compliance documents and is waiting for emergency use authorization (EUA) from the FDA to begin manufacturing the drug.
“We will be able to serve all hospitals who require it, no limitations,” said Business Development Director Christopher M. Bamba. “We currently have a lot of inquiries from government hospitals. It will be fast for us to move forward once we get the EUA.”
Lloyd Laboratories obtained a Compassionate Special Permit to manufacture the drug for Recuenco General Hospital in Taguig, which it provided with 600 capsules.
The company said it has the capacity to manufacture 1 million capsules — either 200 mg or 400 mg —per batch, with each batch to take three or four days.
“We are not yet allowed to distribute to drugstores, only hospitals and local government units, as these are limited and controlled products,” Mr. Bamba added.
Lloyd Laboratories said that as affordability is a top concern, the drug will be 30 to 50% cheaper than imported drugs on the market.
“We are not paying any royalties to anyone. That is skipped from the equation. It will also be locally manufactured, so imports were limited to active pharmaceutical ingredients (API) or the raw materials,” said Mr. Bamba. “We are able to (adopt) a low-price strategy, being a local manufacturer and generic company.”
Lloyd Laboratories received technology transfer to produce the drug from India’s Optimus Pharma Pvt. Ltd.
Meanwhile, the company also said it is currently working on manufacturing a COVID-19 vaccine with Chinese pharmaceutical group Livzon Mavpharm, Inc.
The vaccine carries a provisional name of VO-1 and will be a recombinant vaccine that introduces a fusion protein to patients. Antonio D. Ligsay, medical consultant and head of the clinical trials, said facilities in the Philippines have the capacity to produce pre-filled syringes.
The first two phases of the vaccine project have been completed in China. The third phase of clinical studies is currently being administered in the Philippines, Indonesia, and Russia. The study involves 21,500 test subjects, of which the Philippines provided 12,000. — Luisa Maria Jacinta C. Jocson
