Company Statements Archives - Page 7 of 10

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Company Statements

Biocon’s Insulin Manufacturing Facility in Malaysia Receives EIR from U.S. FDA with Voluntary Action Indicated (VAI) Classification, Inspection Stands Closed

Biocon Receives EIR for Small Molecules API Manufacturing Facility for Post – Approval and GMP U.S. FDA Inspection

Biocon’s Small Molecules API Manufacturing Facility Completes Post-Approval and GMP U.S. FDA Inspection

Biocon’s Insulin Manufacturing Facility in Malaysia Completes U.S. FDA (PAI) Inspection

Biocon’s Small Molecules API Manufacturing Facility Completes Pre-Approval and GMP U.S. FDA inspection

Biocon’s Oral Solid Dosage Manufacturing Facility Completes Pre-Approval U.S. FDA lnspection with Zero Observations

U.S. FDA Completes Pre-Approval Inspection of Two New Biocon Biologics Facilities in Bengaluru

U.S. FDA Issues Complete Response Letter for New Drug Application for Insulin Glargine; Commercialization Plans Remain Unchanged

U.S. FDA completes surveillance (routine) cGMP inspection of one of our Biologics Drug Product facilities in Bengaluru

Pre-Approval U.S. FDA Inspection Conducted at Biocon’s Insulins Facilities in Malaysia