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- Marksans Pharma Ltd received final FDA approval for its generic Benzonatate capsules in 100mg and 200mg strengths, bioequivalent to Pfizer's Tessalon Capsules. - The non-narcotic antitussive medication treats persistent cough, bronchitis, pneumonia, and other lung infections by numbing respiratory tract stretch receptors. - Following the regulatory approval announcement, Marksans Pharma shares skyrocketed 9% initially before closing 6.01% higher at Rs 166.32 on NSE. - This approval represents the company's latest FDA success, following previous approval for Loperamide Hydrochloride tablets in November through its wholly-owned subsidiary.
- Marksans Pharma's UK subsidiary Relonchem received marketing authorization from UK MHRA for Exemestane 25mg film-coated tablets, a breast cancer treatment. - The regulatory approval drove Marksans Pharma shares up 1.26 percent to Rs 189.10 in opening trade on November 6. - This follows Relonchem's October approval for Clonidine tablets from UK MHRA, expanding the company's regulatory portfolio in the UK market. - The company maintains a market capitalization of Rs 8,569.33 crore despite trading 47.25 percent below its 52-week high.
- Time-Cap Laboratories, a subsidiary of Marksans Pharma, received an establishment inspection report from the US FDA following a cGMP inspection at its New York facility conducted in April 2025. - The FDA inspection resulted in only one inspectional observation in Form 483 with no data integrity issues identified during the review process. - Marksans Pharma operates globally with manufacturing facilities in India, USA, and UK, focusing on generic pharmaceutical formulations across multiple therapeutic areas including cardiovascular, CNS, and anti-diabetic segments. - The company demonstrated strong financial performance with a 15.7% increase in consolidated net profit to Rs 90.55 crore and 26.5% revenue growth to Rs 708.46 crore in Q4 FY25.
- Marksans Pharma's subsidiary Relonchem Ltd received UK Medicines and Healthcare Products Regulatory Agency (UKMHRA) marketing authorization for Metformin Hydrochloride oral solution in 500 mg/5 ml strength. - The approval represents a significant milestone for expanding the company's presence in the anti-diabetic therapeutic segment within the UK market. - Metformin Hydrochloride oral solution is used to treat type 2 diabetes and serves as an essential medication for patients requiring oral liquid dosage forms. - Marksans Pharma shares gained up to 1.78% following the regulatory approval announcement, reflecting positive market response to the company's expanding portfolio.
