Shares of Indoco Remedies gained 5 per cent to Rs 282 on the BSE in the morning trade on Wednesday, thereby surging 28 per cent in the past four trading days after getting approval from the US health regulator for blood-thinning drug Apixaban tablets. The stock of the pharmaceutical company was trading close to its 52-week high level of Rs 285, touched on April 13, 2020.
"The company has received approval from the US Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Apixaban tablets in the strengths of 2.5 mg and 5 mg," Indoco Remedies said in a press release.
The approved product is therapeutically equivalent to the reference listed drug Eliquis of Bristol-Myers Squibb. Apixaban is an anticoagulant or blood thinner and is used for patients with health problems caused by a blood clot. As per IMS MAT June'20 data, the US market size of Apixaban tablets is $11,037 million.
The management said the company’s domestic business continues to focus on brand building, thrust on the chronic and subchronic segment, as well as, penetration in the North and East Region. The company will selectively launch new products in the Specialty segment to boost growth.
“On the international front, the company’s US business is expected to grow as Abbreviated New Drug Applications (ANDAs) are being commercialised at regular intervals as USFDA’s approvals have started flowing in. Reinstatement of the EU-GMP compliance certificate for Goa Plant-I and the EU-GMP approval of newly acquired solid dosages manufacturing facility at Baddi (Plant-III) will boost the EU business, with the availability of larger manufacturing capacity,” Indoco Remedies said in the annual report of 2019-20.
The company is also consolidating its position in the Emerging Markets through active brand promotion in select markets. The robust pipeline in specialty dosages, viz., ophthalmics and injectables, will enable it to have an upper edge over its competitors in the International business, it said in the future outlook.