Pharma Stock in Focus After Receiving USFDA Approval for Benzonatate Capsules

Synopsis: The shares of this company rose 8.9 percent following a press release announcing USFDA approval for its Benzonatate Capsules, boosting investor confidence.

The share of this company, which is engaged in Primarily operates in the USA, followed by the UK/Europe and Australia. Key clients include large retailers like Walmart, CVS, and Walgreens came in focus after USFD approval

With a market capitalization of Rs 7,642 crore, Marksans Pharma Ltd’s shares on Wednesday made a day high of Rs 171.25 per share, up by 8.9 percent from its previous day’s close price of Rs 157.15 per share. The company’s share has given a return of 208 percent over the last five years.

What happened

Marksans Pharma Limited has received final approval from the USFDA for its ANDA for Benzonatate Capsules USP, 100 mg and 200 mg. This product is bioequivalent and therapeutically equivalent to Pfizer’s Tessalon Capsules, ensuring the same efficacy and safety for patients.

Benzonatate is a non-narcotic antitussive that works by numbing stretch receptors in the respiratory tract, helping reduce persistent cough associated with bronchitis, pneumonia, and other lung infections, providing an important treatment option in the respiratory care segment.

This new product is expected to boost the Firm’s revenue,complementing its existing geographic mix. In Q3 FY26, the revenue contribution was led by the US at Rs 412.4 crore, followed by UK & Europe Rs 258.2 crore, Australia & New Zealand Rs 61.4 crore, and RoW Rs 22.4 crore.

About the Company

Marksans Pharma Limited (incorporated in 1992, headquartered in Mumbai) is a rapidly growing global pharmaceutical company specialized in research, manufacturing, and marketing of finished dosage OTC and prescription (Rx) formulations. The company boasts a strong presence in regulated markets (US, UK, Europe, Australia), serving over 50 countries.

It primarily operates in the USA , followed by the UK/Europe and Australia. Key clients include large retailers like Walmart, CVS, and Walgreens. The company has manufacturing units in Goa (India), the UK, and the USA, with a total capacity of 26 billion units annually.

Financial Highlights: The revenue from operations grew by 10.5 percent to Rs 754 crore in Q3 FY26, corresponding to the same quarter in the last financial year, and the operating margin increased from 20 percent to 21 percent  YoY. Accompanied by a net profit growth of 8.57 percent to Rs 114 crore profit in Q3 FY26, from Rs 105 crore in Q3 FY25, resulting in a positive EPS of Rs 2.50 per share in Q3 FY26. 

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