Strides gets US regulator approval for its drug

Bangalore-headquartered pharmaceutical company Strides Arcolab has received approval from US health regulator for its general anesthetic, Midazolam Hydrochloride injection.

This drug is generally used as a general anesthetic is injected as a sterile non-pyrogenic parental dosage form for intravenous or intramuscular injection.

As per independent market research firm, IMS data, the total market size for Midazolam in the US in 2009 stood at $51 million. The market size for single dose vials is around $31 million and multi-dose vials is $18 million.

“Midazolam will be launched in partnership with Sagent Pharmaceuticals where in Strides is developing and supplying over 25 injectable products for the US market,” the company release said.

The company also said that this injection would be launched in the US market soon, without divulging further details.

Strides Arcolab registered a 84.42 per cent rise in its net profit to Rs40.74 crore for the quarter ended September 30, 2010, over the same period last fiscal.

The company’s total income rose by 35.8 per cent to Rs430.41 crore during this period as compared to Rs19.15 crore in the same period last fiscal.

The company has 129 filings before various health regulators by March-end, from which 32 are in pharma and 97 in the specialities space.

It has already received 38 approvals as of now and is waiting for the remaining 91 drug approvals from the US health regulator.

The mid-size pharma company has 14 manufacturing facilities in six countries, including its joint venture with Aspen in India.