Indian pharma major Lupin says the US FDA is now satisfied with the corrective actions taken at its Mandideep facility in Madhya Pradesh. An official communication has been received from the US agency on the issue.
In May last year, the FDA had warned the company that no new product would be approved until it took corrective action to address the deficiencies in the Mandideep manufacturing plant. It is Lupin's only plant manufacturing cephalosporins, which contribute about 45% of its total revenue.
The FDA inspection found several deficiencies in the Good Manufacturing Standards (GMP) standards set by the agency and issued Inspectional Observations also known as Form 483 listing all the deviations.
It cited Lupin's failure to maintain production, control, or distribution records and failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products to be sterile.
Lupin's Mandideep facility was also found to be lacking in controls to prevent contamination in defined areas regarding operations related to aseptic processing of products. The plant managers also failed to routinely calibrate, inspect, or check according to a written programme designed to assure proper performance of automatic, mechanical, or electronic systems.
"The USFDA issued a warning letter for the cephalosporin (antibiotic compounds) facility of the Mandideep plant (in Madhya Pradesh). The facility was inspected in November 2008 for a routine GMP (good manufacturing practices) inspection. As a result, Lupin had received 15 procedural observations," Lupin sated in a press release while announcing its fourth quarter results for the period 2008-09.
Lupin responded to the 483 observations informing the corrective course of action through a series of letters in the subsequent months. However, US FDA did not find Lupin's responses satisfactory and issued a warning letter dated 7th May 2009, pointing out at least eight violations regarding the manufacturing process.
"The warning letter was issued to provide Lupin with an opportunity to submit additional documentation and explanation to a few selected observations where the FDA felt that the initial responses were inadequate and could be strengthened by further evidence of compliance with enhanced documentation practices," the announcement said.
Subsequent to the enhancements undertaken by Lupin, the Mandideep facility was re-inspected in November 2009 and the company was able to satisfactorily address all of the concerns related to the Warning Letter and the site compliance status was found to be acceptable.
In the last quarter, the FDA also inspected two new sites of the Company at Aurangabad (Liquids) & Indore (Oral Solids and Oral Contraceptives). Aurangabad was found acceptable with no 483's and Indore was found acceptable with one 483 observation which was satisfactorily addressed before the close of the inspection. These recent successful inspections bring the company a step closer to launching liquids and Oral Contraceptives.
Earlier, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) and the Australian Therapeutic Goods Administration (TGA) had also conducted a joint inspection of the Mandideep facility and had found it acceptable.
Speaking of the inspections, Nilesh Gupta, Group President and Executive Director, said, "We are very pleased that we have been able to satisfactorily address the US FDA's concerns and clear the status of Mandideep. We are very proud that our people have been able to make this happen. This achievement is even more commendable in the current heightened regulatory environment and is strong testimony of how we are moving up the regulatory curve. With the recent inspections and satisfactory resolution of all pending concerns at Mandideep, all our facilities have now been inspected in the past year and have been found to be in good shape."