The Chennai-based Orchid Chemicals & Pharmaceuticals Ltd, with its ongoing thrust to penetrate into the US generics market, is expecting a significant growth in its export business from the first half the current financial year. The company, which has scheduled to enter the US market with its cephalosporin generics by July 2005, would also focus on other regulated markets for export of generics in the current financial year.

During the 2004-'05 period, the Rs 689-crore Orchid filed 18 Abbreviated New Drug Applications (ANDAs) as part of its entry into the US generics market, making the company one among the top ANDA applicants from India related to cephalosporin and anti-infective products.

Orchid's state-of-the-art Cephalosporin formulations facility located at Irungattukottai near Chennai was inspected by USFDA without any '483' observation. So far, 9 ANDAs out of the 18 filed till date, covering various dosage forms of injectables, tablets, capsules and dry syrups, were reviewed. Last week, Orchid formally received its first ANDA approval from US FDA for its formulation product Cefazolin for Injection USP, in 500 mg/vial and 1 gm / vial strengths.

Orchid has already entered into exclusive marketing alliances with global generic majors, Apotex and Par Pharmaceutical, for distribution of its identified cephalosporin generic formulations in the US, and with Alpharma, STADA and Par Pharmaceutical for distribution of select products of diverse therapeutic groups in the US and Europe. As per the tie-up with STADA Pharmaceuticals, Inc., the US subsidiary of STADA Arzneimittel AG, Orchid will develop and supply six prescription generic drug products to STADA for the US market in the therapeutic areas of cardio-vascular, central nervous system, anti-allergic, gastrointestinal and anti-infective categories. The current US brand market size of these products aggregates to around USD 12.5 billion. Orchid would commence supply of these products once they go off patent progressively from 2007 onwards, based on regulatory filings and approvals.

According to K Raghavendra Rao, Managing Director, Orchid Chemicals & Pharmaceuticals Ltd., Orchid looks forward to significant growth momentum from cephalosporin generics foray starting July 2005. "The current fiscal will also witness the completion of our new US FDA-compliant non-antibiotic manufacturing facilities (both bulk & formulations). This will lead to a slew of DMFs and ANDAs in the new product groups. Given the progress achieved and initiatives that would pan out, we anticipate the current fiscal to contribute robust revenues and build further value for the business," said Rao.

Meanwhile, the company said its domestic formulations business with Orchid Healthcare and Mano Pharma was adversely impacted by the slow-down in the trade channels due to VAT related issues, affecting its overall formulations turnover, at Rs 96.20 crore during 2004-'05, compared to Rs 104.41 crore last year. The company had restructured its domestic business by concentrating in the areas of neuro-psychiatry, cardiovascular, anti-diabetes and critical care to achieve sharper focus and higher productivity.

Orchid's sale of bulk actives accounted for only Rs 600.93 crore in 2004-'05, as compared to Rs 624.55 crore during the previous fiscal. During 2004-'05, the company filed Additional Drug Master Files (DMFs) for key cephalosporin APIs with the USFDA, taking the consolidated count to 16 DMFs with the US FDA. Orchid intends to get more of its facilities and products approved by leading agencies during this year. Orchid announced its manufacturing JV in China, NCPC Orchid, recorded revenues of USD 25 million for the first full year of operations. The JV manufactures high-end injectable cephalosporin APIs for the Chinese market.