The US Food and Drugs Administration's (FDA) warning letter to RPG Life Sciences about its two manufacturing facilities in India might delay the company's plans to foray into the US, the world's largest pharmaceutical market.
Although the Mumbai-based drug maker has hired Lachman Consultants in line with the FDA directive to take corrective measures, the facilities have to be re-inspected and approved by the US regulator all over again.
According to an official spokesperson of RPG Life, the firm is keenly eyeing the US market for future growth. In that context, as a standard procedure, its manufacturing facilities underwent a pre-approval inspection by the US FDA, which issued a warning letter to the company on May 28, citing violations of its good manufacturing norms at RPG Life Sciences' facilities at Ankleshwar (Gujarat) and Navi Mumbai (Maharashtra).
"The US FDA made some observations and recommendations. Immediately thereafter, we have engaged with Lachman Consultants, a renowned global consultant, to make our systems and processes comply with the US FDA guidelines," said the official spokesperson, adding that the company is confident of matching the regulator's requisite standards during the next round of audits.
According to sources, Lachman is also among the two consultants hired by Ranbaxy to assist in its ongoing consent decree signed with the US FDA for its two facilities under import alert.
While detailing the nature of violations observed in the firm's two facilities during inspection, the US FDA's warning letter, addressed to RPG Life Sciences' Managing Director Ajit Singh Chouhan, said the regulator may withhold approval of any new application from the company till corrective measures are completed and confirmed.
"Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm's compliance with CGMP (current good manufacturing practice), FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer," the letter said, adding FDA may even bar supplies of drugs to the US from these facilities if the company fails to correct violations.
However, the firm said currently, it does not sell any product or active ingredient in the US.
RPG Life Sciences, a part of the Rs 17,000-crore RPG Enterprises, is an integrated pharmaceutical company operating in the domestic and international markets in the branded formulations, global generics, synthetic and fermentation APIs (active pharmaceutical ingredients) space. Apart from India, the company has operations in Europe and Canada. According to its website, the company currently has several tie-ups with international partners as well.
On Wednesday, shares of RPG Life Sciences Ltd ended at Rs 62.55 on the Bombay Stock Exchange, down 0.89 per cent from their previous close.