Strides Arcolab gets USFDA approval for its anti-cancer injection

Shrikant / 04 Nov 2011

Strides Arcolab is trying to gain from a shortfall in the supply of Doxorubicin Hydrochloride injections in the market, and we, at DSIJ, see a favourable impact of the same in its revenues.
Indian pharmaceutical companies have been increasing their ANDA portfolio for quite a long time now. There are opportunities available, and Indian companies are riding on it. Strides Arcolab, which is in the business of manufacturing branded generics and injectables, has received USFDA approval for its Doxorubicin Hydrochloride injection in 10 mg and 50 mg vials. Doxorubicin Hydrochloride is a chemotherapy drug, mainly used in the treatment of a wide range of cancers.

According to the data published on the website of the US Food and Drug Administration, there is a shortage of Doxorubicin Hydrochloride in the US market. It is very clear that Strides Arcolab is trying to gain from the shortfall of this product in the US market. This product will be manufactured by its manufacturing unit Agila, and will be supplied to Pfizer, which is a giant pharma company in the global market.

In the last month, the company has received two ANDA approvals for Bupivacaine Hydrochloride injection USP, which is mainly used for anesthesia. The market size for Bupivacaine is $29 million, while that of Doxorubicin is about $16.8 million.

According to a presentation uploaded by the company on its website, it derives 23% revenues from the North American market, which witnessed a growth of 200% in 2010. It also indicates that the global injectables market is $200 billion, of which the largest chunk of 39%, is formed by America. The company has built many products especially for the US market, and we believe that the new approvals are a part of the same.

As of September 2011, Strides Arcolab holds a portfolio of about 44 ANDA flings, of which 9 have been approved. Many drugs are coming off patent, and Indian companies are largely benefiting from this. India has a low-cost manufacturing facility, which increases their competitiveness in the market. Companies like Ranbaxy Laboratories, Aurobindo Pharma, Jubilant Life Sciences, etc., each of which also have a robust portfolio of ANDAs, have shown significant growth in their revenues.

We made enquiries about the financial details, but the company's spokesperson declined to comment on it. Going by the performance of the Indian companies in generics business, we believe that this brings a good opportunity to Strides Arcolab, and see a highly favourable impact of the same on its revenues.

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