The US Food and Drug Administration (FDA) has rapped Ranbaxy for not maintaining its Toansa plant in line with the required standards, reports fe Bureau in New Delhi. In an observation letter sent to the drug major last week, the USFDA noted that Ranbaxy’s Toansa (Punjab) plant did not conform to “established equipment maintenance programmes and procedures” that would ensure raw materials manufactured at the plant were of standard quality and purity. The Ranbaxy stock lost 5.42% on Monday closing at R438.35 on the Bombay Stock Exchange (BSE).
According to sources, the FDA wrote in the Form 483 that equipment maintenance programmes at Toansa were “deficient and sampling plans and procedures were not scientifically sound and appropriate” to ensure that raw materials were in line with established standards of quality.
About 70% of active pharmaceutical ingredients (APIs), or raw materials, used by Ranbaxy in its formulations (finished drugs) are manufactured at the Toansa plant. Moreover, analysts say a few important FTFs may be impacted. “First to file opportunities for Diovan, Valcyte and Nexium may be dependent for API supplies, from this facility,” analysts Anshuman Gupta and Perin Ali of Edelweiss wrote in a note.
The total revenues from the launches of these three products are estimated at $800 million, during the six-month exclusivity period. Diovan, which was to be launched in September 2013 has been delayed.
A Ranbaxy spokesperson said: “On Saturday, January 11, 2014, Ranbaxy received the form 483 with certain observations as a result of the recent US FDA inspection at its API plant at Toansa, Punjab, India. The company is assessing the observations, and will respond to the US FDA in accordance with the agency’s procedure to resolve the concerns at the earliest”.
While a form 483 is used by FDA to document and communicate concerns discovered during inspections, it does not mean the regulator has concluded that the unit is guilty of manufacturing malpractices or has banned products from them.
Analysts said that if Ranbaxy is able to resolve FDA’s concerns in Toansa, it may become easier to rectify manufacturing and quality issues at other Indian plants which have been banned from selling drugs to US. “With Toansa plant also under scanner, it would have an impact on the operations of the company in US unless it can compensate for the same at the earliest and manage a smooth supply of key materials,” said Sarabjit Kour Nangra, vice-president (research), Angel