New Delhi: The US drugs regulator, which recently inspected two manufacturing plants of Dr Reddy’s Laboratories Ltd (DRL) has cleared one plant and given a minor observation at the other. The team of inspectors from the US Food and Drug Administration (FDA) is also expected to inspect Lupin’s Mandideep facility in Madhya Pradesh and Ranbaxy’s Tonsa plant in Punjab by the end of this year.
DRL’s Bachupally plant in Andhra Pradesh received one 483, or an observation from the investigator that there is some deviation from current Good Manufacturing Practices (cGMPs). Meanwhile, its Vizag facility, which had previously been given 483s, was cleared by the team.
According to the company spokesperson: “The US FDA wanted to visit the facility for three reasons—the facility’s bi-annual audit was due in December-January, DRL had eight ANDAs (abbreviated new drug applications—an application to market a generic drug only in the US) filed from this plant and FDA wanted to conduct a for-cause audit as DRL had recalled products from the US market. Following this visit, FDA has recommended for approval all eight ANDAs.”
“(DRL) management indicated that the outstanding 483s at the Vizag plant have been cleared, while the Bachupally plant received just one minor 483,” stated a 23 November Citi Investment Research report by analysts Prashant Nair and Akshay Rai.
In September, DRL had voluntarily recalled one lot of four of its products from the US market as a precautionary measure because the affected batch had been observed to contain some oversized tablets. The recall had led to investor concerns over DRL’s manufacturing practices, in view of the existing 483s at its Vizag plant.
“DRL will have to reply to the 483 within one month and will have to give FDA a time frame on when it will address the observation,” said Ranjit Kapadia of HDFC Securities. “However, it doesn’t appear to be anything major for DRL.”
FDA has gradually become very stringent on GMPs and is routinely cracking down on companies and plants that are not up to its standards.
Two Indian companies—Ranbaxy Laboratories Ltd and Lupin Ltd—also have received warning letters from FDA regarding its plants. Lupin had initially received 483s for its Mandideep facility, which later turned into warning letters. Ranbaxy has two warning letters—one for its Dewas unit in Madhya Pradesh and another for its Paonta Sahib plant in Himachal Pradesh. FDA had raised concerns regarding cross-contamination at the company’s plants. Ranbaxy expects FDA to inspect its Dewas plant within two months and its Paonta Sahib plant is to be inspected in another six months.
Earlier this year, FDA had also inspected and given 483 observations to Cipla Ltd for two of its facilities, one in Goa and another in Bangalore.
