Mumbai: Bengaluru-based drug maker Strides Shasun Ltd plans to step up product filings with the US regulator starting in the current financial year, as it seeks to expand in the world’s largest drug market, executive director Badree Komandur said.
The company plans to file 15-20 abbreviated new drug applications (ANDAs) with the US Food and Drug Administration (FDA) annually, as against 10-12 applications earlier, he said, adding that on a quarterly basis, Strides intends to file 4-5 ANDAs.
“Regulated markets like the US and Australia will be the real focus of the company. Our R&D (research and development) pipeline and product commercialization will drive growth,” Komandur said.
In 2016-17, the company’s sales in regulated markets were Rs1,776.2 crore, up 56% from the previous year.
Over the last two years, the company has significantly increased spending on R&D with focus on products with specified modified-release technologies, Komandar said. Spending on R&D was 80% higher on-year at Rs136.1 crore in 2016-17.
Strides received approval for six products in the US last fiscal year and it currently has 32 ANDAs awaiting US FDA approval. The company expects 15-20 product approvals in North America in the current year, according to its earnings statement.
“Once we start getting more approvals and that is expected because all our plants have been inspected and got clearance, the momentum in US will pick up,” Komandar said.
In the quarter ended March, Strides reported consolidated net profit of Rs131.9 crore, compared with Rs4.43 crore a year ago. Revenue fell to Rs888.41 crore from Rs924.32 crore due to weak institutional business performance and lower sales of active pharmaceutical ingredients (APIs).
In February, the company announced plans to demerge its API business into a separate entity, which will subsequently be listed on the stock exchanges.
The company’s de-merged API business, along with the API business of Sequent Scientific Ltd (which is owned by the promoters of Strides), will together form a new company called Solara Active Pharma Science. The completion of this deal is likely in the December quarter, Komandar said.
Separately, Strides said on Thursday that it had signed definitive agreements with Vivimed Labs Ltd to for two 50:50 joint venture (JV) companies, one each in India and Singapore. The total investment in these JVs is Rs75 crore.
The Indian JV will own a US FDA-approved formulations facility in Chennai, and the Singapore JV will own certain approved ANDAs and product pipeline. This transaction is expected to close by the end of this month.