Dalal Street

Sun Pharmaceutical Industries has announced that United States Food & Drug Administration (USFDA) has granted its subsidiary an approval for an abbreviated new drug application (ANDA) for generic Casodex, Bicalutamide tablets.

These tablets are an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate. Bicalutamide tablets are generic version of Casodex tablets from AstraZeneca, having annual sales of approximately $314 million in the US market.

Recently, the company received a tentative nod from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for the generic version of Optivar, azelastine ophthalmic solution 0.05%. The approval will enable the Indian pharma major to market the drug in the US market.

The sterile azelastine ophthalmic solution is the generic version of Optivar Ophthalmic Solution manufactured by Medpointe Pharmaceuticals, which has annual sales of around $48 million in the US market.

The drug is recommended for the treatment of the itching of the eyes associated with allergic conjunctivitis.

Last month, the USFDA seized drug products manufactured by Caraco Pharmaceutical Laboratories (Caraco) – the US subsidiary of Sun Pharma – at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom.

According to the FDA, Caraco repeatedly failed to meet current Good Manufacturing Practice (cGMP) requirements, which guarantee the quality of manufactured drugs. Following this action, the company has been asked to instantaneously stop from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.

Godawari Power & Ispat’s (GPIL) Standalone Top-line fell by a whopping 34.8% yoy to Rs171.8cr (Rs263.4cr) in 4QFY2009. This de-growth was on account of a 46% decline in the revenue from the steel division, and due to the production cut undertaken by the
company in its Steel Billets and Ferro Manganese segment (for the purpose of increasing the sales volume of the power division). However, the sales from Sponge Iron increased by a massive 235% yoy to Rs84.9cr (Rs25.4cr). For FY2009, the company’s standalone and Consolidated Top-line increased by 24.9% and 35.1%, respectively.

GPIL’s Standalone net profit stood at Rs9.7cr (Rs28.8cr), for the quarter, down 66.2%. This fall was primarily on account of the decline in the operating profit. The company’s FY2009 standalone and consolidated net profits declined by 39.6% and 37.7%, respectively.