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The USD 40 billion generic market is our topmost priority. We are present in the US directly, through Sun Pharmaceutical Industries Inc., and through our subsidiaries Taro and Caraco. Between Sun Pharma, Taro and Caraco, currently over 149 filings await approval (December 2010). Our pipeline is a mix of simpler generic filings, complex filings like those for derma products, injectables or sprays and a few patent challenges.
So far, we've had success as a generic company with the advantages of several acquisitions, supported by manufacturing integration and product development in India. Our 2010 acquisition of Taro Pharma brings in manufacturing capability in Canada and Israel, and a strong list of ANDAs, specially in dermatology.
With significant balance sheet strength, we continue to be on the lookout for acquisition opportunities in the US generic pharma space, particularly for companies where we can streamline the business and create sustainable value.
Taro USA develops, manufactures and markets prescription and OTC products, primarily in the United States (as well as in Canada and Israel), and in most of these markets a dedicated field force is in place. We will now work to maximize the opportunity that this pipeline offers.
We had initially invested $7.5 million in Caraco in 1997. The subsequent scaling up of its business saw revenues moving from US $0.8 million in 1997 to over USD 112 million in March 2009, and inspired our longer term plans for the US. So far, Caraco has been competing as a generic manufacturer that is integrated for some of its bulk actives to Sun Pharma's API sites in India. The thirty or so ANDAs that Caraco holds registrations for, included products where it was amongst the top 3 in terms of market share prior to the cessation of manufacturing in June 2009.
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On 25th June, 2009, the Food and Drug Administration seized drugs manufactured at Caraco on account of unresolved violations of cGMP requirements. Caraco has been actively working with cGMP consultants to resume manufacturing. Subsequently, Caraco entered into a Consent Decree with the FDA on September 29, 2009. Under the terms of the consent decree, Caraco's cessation of manufacturing will continue until it receives written notification from independent experts and the FDA that it is in compliance with the Consent Decree and regulations and can resume operations.
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We also have a USFDA approved site in Halol, India. This large manufacturing site follows international systems and processes and can make a range of dosage forms across tablets, capsules, ophthalmic and difficult-to-make products like injectables, nasal sprays and soft gel capsules. Of specific interest is the existence of special dedicated areas to manufacture dosage forms for categories such as steroids, anticancer and hormones.
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In 2005 we acquired two plants - in Cranbury, New Jersey and in Bryan, Ohio.
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The Cranbury facility (the erstwhile Able Labs) offers 275,000 sq. ft. with special suites for the manufacturing of controlled substances. The controlled form manufacturing at this site ties in with the acquisition last year of a company in Hungary. Our Hungarian site (ICN Hungary, formerly known as Alkaloida) is one of the few worldwide authorized to make API for controlled substances. Over time, once the required regulatory approvals are received, we intend to compete in the US market as an integrated generic company in this high value area.
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Lotions, ointments and liquids is an interesting area. Our Bryan, Ohio, facility equip us to compete in this product opportunity at a sensible cost.
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Click here to view Caraco's product list.
Click here to view Taro's product list.
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