Drug major Lupin's manufacturing capabilities have come under the scanner of the US drug regulator, as it has detected deficiencies across multiple sites in recent inspections.
US Food and Drug Administration (USFDA) last week certified two of its facilities. The USFDA announced that the inspection conducted at its Tarapur active pharmaceutical ingredient (API) manufacturing facility in Maharashtra from September 16 to September 20 last year has been classified as Official Action Indicated (OAI). The regulator found three deviations from the current Good Manufacturing Practices (GMP) standards. A couple of days ago, Lupin said that it had received two observations from the US health regulator following the inspection at its Nagpur manufacturing facility, one of its most modern plants.
With this, at least six of Lupin's manufacturing facilities, out of its 18 units, are now short of the requisite standards prescribed by the USFDA. Of late, Indian drug firms are increasingly receiving warning letters from the USFDA. The Indian pharmaceutical companies received 19 warning letters, out of the 41 (46 per cent) issued by the Office of Manufacturing Quality of the USFDA in 2019, the most in recent years.
"A PAI (Prior Approval Inspection) was carried out by the United States Food and Drug Administration (USFDA) at the company's Nagpur oral solid dosage manufacturing facility between January 6-10, 2020 and the inspection closed with two 483 observations," Lupin informed the stock exchanges. The Nagpur facility is Lupin's most modern tablet making facility, and the USFDA had conducted seven inspections at this facility.
Since the manufacturing deviations at both these facilities are not a worrying factor at present and may not lead to a warning letter immediately, there needs to have more vigil on the part of the company to address the issues at its various plants, said industry observers.
"We are committed to meeting the highest quality standards and are committed to full compliance with CGMP regulations at all our manufacturing facilities. We will address the observations raised by the agency satisfactorily and will submit our comprehensive response within the stipulated timeline," says Nilesh Gupta, managing director.
Recently, Lupin had to sell its Japanese subsidiary Kyowa Pharmaceuticals for $300 million to reduce its debts. After completion of this deal, Lupin's net debt will come down to Rs 1,129 crore, compared to Rs 4,362 crore as on September 30, 2019. Lupin's main business in the US was undergoing pricing pressure and a big acquisition had gone wrong in the past.
Commenting on the Tharapur inspection, Lupin said the inspection classification would not have an impact on disruption of supplies or the existing revenues from operations of this facility. The company is in the process of sending further updates of its corrective actions to the USFDA and is hopeful of a positive outcome.
In October, Lupin had got another setback when its Unit-1 facility at Mandideep in Madhya Pradesh was slapped with a warning letter. Lupin had then said the letter was subsequent to an earlier intimation received from the USFDA in March last year, after it classified its earlier inspection with an OAI with three observations. Similarly, its Goa facility had also got an OAI. It means there are manufacturing issues that may lead to warning letter and then, if not rectified, a ban. "There are no drug master file (DMF) and abbreviated new drug application (ANDA) pending review or approval from the Mandideep unit one facility and the warning letter will not have an impact on disruption of supplies or the existing revenues from operations of this facility," Lupin had maintained.
The inspection held by the USFDA at its Pithampur (Indore) Unit-2 facility in January 2019 had also saw manufacturing deviations. It was classified as Official Action Indicated (OAI). The USFDA had also classified the inspection conducted at Lupin's Somerset (New Jersey) facility in December 2018, as OAI.
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