The two Chennai based companies, Orchid Chemicals and Pharmaceuticals and Shasun Chemicals and Drugs Ltd., are stepping forward in API business focusing more on the regulated market, by underscoring its endeavor on setting up new markets, tie-ups and acquisitions.
Orchid Chemicals, with its focus on cephalosporin products, has progressed well in the regulatory roadmap with a fair list of ANDA and DMF filings and the list continues to grow, as the company plans to file atleast two ANDAs and DMFs per month in the current year.
Orchid has filed DMFs with the USFDA for additional key antibiotic APIs as well as the first non-antibiotic API, in the financial year 2005-06. The company, with 28 DMFs filed till date with the USFDA, plans to file around 25 DMFs and ANDAs in the current year. The company has filed 26 ANDAs till date and plans to continue the regulatory momentum in broader product segments, in the year 2006-07. In the last six months, the company has filed 7 DMFs and 7 ANDAs, which shows the growth of company in the regulated market.
The non-penicillin, non-cephalosporin (NPNC) space, with setting up manufacturing facility at Aurangabad in the last quarter of 2004-2005, earmarked the companies foray into the NPNC space in the regulated market. Orchid's NPNC space has marked by a strong product basket of several molecules covering diverse therapeutic groups like CNS, CVS, ADD, urology, osteoporosis etc. Some of these products are expected to provide Para-IV / first-to-file (FTF) opportunities to the company.
The company has filed two DMFs and one ANDA in the NPNC space in 2005-06. Orchid is targeting to progress on the filing calendar in an aggressive pace during this year, according to the company sources. Eyeing the marketing opportunities of the NPNC range including the products, the company has entered into exclusive distribution alliances with large global majors like Alpharma (now Actavis), Stada and Par Pharma.
By opening a multi-purpose bulk drug facility has been established at Aurangabad, the company at present has API and Non-sterile API drug facility in Alathur and API and Sterile API facility at Aurangabad.
Orchid is planning to enter into Japan with its API strength by the financial year 2008-09, expecting to leverage USD 64.7 million from the area by the year 2011. The company expects its US API market initiations to hit USD 13.5 million by the time to accomplish its target of USD one billion by the year 2011. The vision is to hit 78% of its production to the regulated market and the rest of 22% to the un-regulated market.
Shasun Chemicals, with its two API manufacturing facilities at Pondicherry and Cuddalore, is also focusing on the regulated market with its API and formulation strength. With the main focus on its anti-inflammatory drug ibuprofen, Shasun is also engaged in production of nizatidine, gabapentine, isradipine, ranitidine HCl and methohexital.
The company, aspiring the leadership status in all the products under its umbrella, also offers pre-formulations and value-added derivatives prepared in-house to lower the development costs of its clients, to provide them a competitive edge, as its business strategy.
Inspected by the FDA, MCA and other regulatory bodies from the regulated market, Shasun's products are sold in more than 40 countries all over the world. Its supply chain includes Boots Co, UK - the original innovator of Ibuprofen and offers a spectrum of ibuprufen derivatives such as S+ ibuprofen, ibuprofen lysinate and ibuprofen sodium.
Shasun's endeavor to succeed in the generic manufacturing along with API found to be a success, as the company marks a continues growth in market for the last few years. The market results upto the third quarter of the financial year 2005-06 shows a 43% growth in the net profit at Rs.12.90 crore as compared to Rs.9.01 crore in the third quarter of the financial year 2004-05. The company has also posted a 15 rise in the net sales at Rs. 255 crore for the first nine months of the last finanicial year.
The company has acquired the pharmaceutical custom synthesis business of the Rhodia group in the second half of FY 2005-06 and announced an investment of about USD 35 million in this business within the next two years. According to the acquisition terms, the transaction included manufacturing sites at Dudely and Annan located in UK with few technological patents. The company has also tie-ups with Alpharma Inc., Inva Gen Inc. and Glenmark Pharmacueticals to market its products in US and Eurpean markets.