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US FDA ‘Satisfied’ With Indian Pharma’s Manufacturing Facility
“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."
Source-Medindia
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