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This is an important milestone in Biocon’s journey of developing insulin Glargine for patients in the US, said a company spokesperson. The Bengaluru-headquartered biotech firm’s insulin Glargine (Semglee) application filed by its partner Mylan, with the USFDA under the 505(b)(2) NDA pathway, is currently under review.
“This is to inform you that Biocon Sdn Bhd, a subsidiary of Biocon, has received the EIR from the USFDA for the pre-approval inspection of its insulins manufacturing facility in Malaysia, for Insulin Glargine. The inspection was conducted between Feb 10 and 21, 2020,” said the company spokesperson in a statement.
The inspection has been closed with a voluntary action indicated classification in the EIR for the three observations issued at the conclusion of the inspection.
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