The Indian national drug manufacturing regulators have cleared Ranbaxy’s Malaysian operations.
The national drug manufacturing regulators have cleared Ranbaxy’s Malaysian operations and free from any practices that had the Indian company admitting to “felony charges” in the US for violating manufacturing practices at its plant in India recently.
The National Pharmaceutical Control Bureau (NPCB) said it conducted an inspection at Ranbaxy’s Kedah plant and found it to conduct good manufacturing practices.
The NPCB is currently inspecting the Bioequivalence (BE) provider — studies required for generics — which is in India, the NPCB told The Malaysian Reserve.
The questions on safety of drugs produced by Ranbaxy Malaysia were raised after Ranbaxy was accused of violating drug manufacturing standards. The update on NPCB’s practice has come soon after an article appeared in The Malaysian Reserve about Ranbaxy Malaysia’s Kedah plant.
In its response, Ranbaxy said: “We have engaged with the National Pharmaceutical Control Bureau, Ministry of Health Malaysia, and assured them that Ranbaxy’s medicines meant for distribution in Malaysia are manufactured as per good manufacturing practice and in accordance with NPCB approved registrations.”
Following the admission to US regulators, the Indian regulators also conducted checks on the company’s Indian operations.
In May, Ranbaxy pleaded guilty to “felony charges” in the US and agreed to pay a US$500 million (RM1.6 billion) penalty for violation of approved drug manufacturing standards at its two plants in India. The incident led the company’s stocks to tumble.
Ranbaxy Malaysia Sdn Bhd, the Malaysian arm of Ranbaxy Laboratories, aims to make it big in Malaysia by becoming a US$100 million company.
The company is setting up a greenfield manufacturing facility as an Entry Point Project in Malaysia with an investment of around RM125 million. The drugs manufactured by the company in Malaysia are sold in Malaysia, Singapore and other countries.