Orchid Chemicals receives 3 USFDA approvals for ANDAs in Q2

Orchid Chemicals & Pharmaceuticals Ltd has announced about the following:

"The second quarter has been a satisfying one on key strategic fronts. We received 3 USFDA approvals for our ANDAs during this quarter and in October taking the total ANDA approval count to 18. Importantly, both our API and Formulations sterile cephalosporin facilities were approved by the UK-MHRA (Medicines and Healthcare products Regulatory Agency). This would be a major enabler for our broader entry into the large EU generics space. With more product introductions slated in the ensuing quarters based on progressive approvals, we are confident of achieving a strong performance during the further quarters also", said Mr. K Raghavendra Rao, Managing Director, of the Company.

US Generics

During the second quarter, the Company continued to derive significant revenue and profitability from the US generics business. During the quarter, the Company increased its US market presence by launching 2 more generic cephalosporin formulations based on approvals, received. The total product count of the Company approved for the US as of date stands at 18 ANDAs.

The Company is also strongly consolidating its position in a key injectable product in the US. With the migration of its API customers to finished dosage supplies, the Company will have a dominant share of this market, which has of late been constrained by supply shortages. In addition to the regular distribution arrangement for this product with Apotex, the Company has also initiated supply agreements with select US genetic distributors.

Source : Equity Bulls

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