Business

FDA concludes inspection of Biocon's insulin unit in Malaysia

Kiran Mazumdar-Shaw is the Chairperson and Managing Director of Biocon

Kiran Mazumdar-Shaw is the Chairperson and Managing Director of Biocon   | Photo Credit: SOMASHEKAR G R N

The inspection, which was carried out between February 10 and February 21, 2020, has been closed with a “VAI” (Voluntary Action Indicated) classification in the EIR

Bengaluru Biocon Sdn Bhd, a subsidiary of Biocon Limited has received the Establishment Inspection Report (EIR) from the U.S. FDA for the Pre-Approval Inspection (PAI) of its manufacturing facility in Malaysia, for Insulin Glargine, as per a stock market filing made by the company on Wednesday.

The inspection, which was carried out between February 10 and February 21, 2020, has been closed with a “VAI” (Voluntary Action Indicated) classification in the EIR, for the three observations issued at the conclusion.

"This is an endorsement of our commitment to global standards of Quality and Compliance. The closing of the USFDA Inspection of our Malaysia Facility is an important milestone in our journey of developing Insulin Glargine for patients in the US.”

The company's Insulin Glargine (Semglee®) application filed by its partner Mylan, with the USFDA under the 505(b)(2) NDA pathway, is currently under review, as per the biotechnology firm.

Insulin glargine is a long-acting insulin, used in the management of type I and type II diabetes.

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Printable version | May 25, 2020 9:16:21 PM | https://www.thehindu.com/business/fda-concludes-inspection-of-biocons-insulin-unit-in-malaysia/article31224572.ece

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