Image Source: Voisin Consulting
Marksans Pharma Limited, a leading Indian pharmaceutical company, has achieved a significant regulatory milestone in its global expansion strategy. The company announced that its wholly owned UK-based subsidiary, Relonchem Limited, has received marketing authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for three formulations of Metformin Hydrochloride oral solution.
This approval marks a major step forward for Marksans Pharma in strengthening its presence in regulated markets like the United Kingdom. The authorized product—Metformin Hydrochloride 500mg/5ml Oral Solution—is a widely prescribed medication for the management of type 2 diabetes, especially for patients who require liquid formulations due to difficulty swallowing tablets.
What the Approval Means
The MHRA’s marketing authorization allows Relonchem to manufacture, market, and distribute the Metformin Hydrochloride oral solution across the UK. This is particularly impactful for diabetic patients who need flexible dosage forms and for healthcare providers seeking alternatives to solid oral tablets.
Metformin Hydrochloride is a cornerstone in the treatment of type 2 diabetes, helping to control blood sugar levels and reduce the risk of complications. The oral solution format is especially beneficial for pediatric, geriatric, and dysphagic patients—those who have trouble swallowing pills.
Marksans Pharma’s move to offer this formulation aligns with its broader strategy to deliver value-added generics that cater to underserved patient needs in global markets.
Strategic Expansion in Regulated Markets
This regulatory win is part of Marksans Pharma’s ongoing efforts to deepen its footprint in highly regulated markets such as the UK, US, and Australia. The company’s manufacturing facilities are already approved by top global agencies including the USFDA, UKMHRA, and Australian TGA.
With this latest approval, Marksans is poised to enhance its product portfolio in the UK, where demand for high-quality, affordable generic medications continues to grow. The company’s focus on therapeutic segments such as cardiovascular, central nervous system, antidiabetic, pain management, and gastroenterology positions it well to meet evolving healthcare needs.
Market Response and Financial Impact
Following the announcement, Marksans Pharma’s stock saw a modest uptick, trading at ₹261.35 on the Bombay Stock Exchange (BSE), up 0.38%. Investors responded positively to the news, viewing it as a sign of the company’s regulatory strength and international growth potential.
In its recent quarterly report, Marksans Pharma posted a 25.6% increase in consolidated net profit to ₹104.56 crore, alongside a 16.3% rise in revenue from operations to ₹681.85 crore in Q3 FY25 compared to Q3 FY24. The MHRA approval is expected to further boost the company’s revenue streams from its UK operations.
Innovation in Formulation
The approval of the Metformin Hydrochloride oral solution also reflects Marksans Pharma’s commitment to pharmaceutical innovation. By offering alternative dosage forms, the company is addressing real-world patient challenges and improving medication adherence.
This is especially relevant in chronic conditions like diabetes, where long-term treatment compliance is critical. Liquid formulations offer flexibility in dosing and are easier to administer, particularly in institutional settings such as hospitals and care homes.
What’s Next for Marksans?
With the MHRA’s green light, Marksans Pharma is expected to begin commercial rollout of the Metformin oral solution in the UK in the coming months. The company may also explore similar approvals in other European markets, leveraging its regulatory success to expand its reach.
This development reinforces Marksans Pharma’s reputation as a reliable manufacturer of high-quality generics and its strategic vision to become a global pharmaceutical powerhouse.
Sources: Business Standard, Business Upturn, CNBC TV18
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