The Mumbai-based Wyeth India has resumed production of Penidure LA, which was temporarily stopped due to the switch over from the earlier contract manufacturer to the new. The Penidure LA, penicillin injection used for rheumatic heart disease, has been in short supply for four months now.
While talking to Pharmabiz, Ranga Iyer, managing director, Wyeth India, said that the company has resumed production of Penidure and is now making all efforts to get the drug to the market as soon as possible. "At present, we are just waiting for the stability test report. Once it is ready, the product will be immediately available in the market," he said.
Last year, the company had to switch its manufacturing operations to a different manufacturer. Following which the entire batch production had been affected due to some delay in the whole shifting process and the related approval problems. Meanwhile, Penidure (LA 6, LA12 and LA 24), continues to be out of stock with retail chemists here, according to RDCA sources.
To tide over the shortage, cardiologists have been prescribing penicillin tablets, or the erythromycin group of drugs, as alternatives. Patients typically need the injection every 21 days to guard against infections. About six to eleven per thousand schoolchildren suffer from rheumatic heart disease in India. The World Health Organisation recommends that penicillin be administered lifelong to such patients. Based on studies in India, doctors recommend taking it till the age of 35.