Eugia Pharma receives USFDA Approval for Triamcinolone Acetonide Injectable Suspension

Aurobindo Pharma Limited has announced that its wholly owned subsidiary company, Eugia Pharma Specialities Limited, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Triamcinolone Acetonide Injectable Suspension 200 mg/5 mL & 400 mg/10 mL. Triamcinolone Acetonide Injectable Suspension USP, 200 mg/5 mL (40 mg/mL) Multiple-dose vials and 400 mg/10 mL (40 mg/mL) Multiple-dose vials, to be bioequivalent and therapeutically equivalent to the RLD, Kenalog-40 Injectable Suspension, 40 mg/mL, of Bristol-Myers Squibb Company. The product is being launched this month. The approved product has an estimated market size of around US$ 73 million forthe twelve months ending May 2022, according to IQVIA.

This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.

Triamcinolone Acetonide Injectable Suspension is in therapeutic Category of Synthetic glucocorticoid corticosteroid and indicated for the treatment of Intramuscular and Intra-Articular use:

Intramuscular - Where oral therapy is not feasible: allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders, neoplastic diseases (palliative treatment), nervous system, ophthalmic diseases, renal diseases, respiratory diseases, rheumatic disorders

Intra-Articular - adjunctive therapy for short-term administration in: acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 533.30 as compared to the previous close of Rs. 528.65. The total number of shares traded during the day was 37059 in over 1757 trades.

The stock hit an intraday high of Rs. 544.90 and intraday low of 528.50. The net turnover during the day was Rs. 19906766.00.

Source : Equity Bulls

Keywords

AurobindoPharma INE406A01037 EugiaPharmaSpecialities FinalApproval USFDA