US Food and Drug Administration (USFDA) has issued six observations after the inspection of the manufacturing facility of Biocon’s Malaysian subsidiary Biocon Sdn Bhd. USFDA conducted an on-site pre-approval inspection of the company's Malaysian subsidiary Biocon Sdn Bhd's manufacturing facility for Insulin Aspart between September 13 and September 24, 2021. At the conclusion of the inspection, the agency has issued a Form 483 with a total of 6 observations across Drug Substance, Drug Product and Devices Facilities.
Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.
Company Name | CMP |
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Sun Pharma Inds. | 1481.35 |
Dr. Reddys Lab | 5981.75 |
Cipla | 1357.35 |
Zydus Lifesciences | 962.20 |
Lupin | 1584.50 |
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