Marksans Pharma Limited, a pharmaceutical company based in Mumbai, has announced that its wholly owned subsidiary Relonchem Limited has received Marketing Authorization from the UK Medicines and Healthcare Products Regulatory Agency (UKMHRA). The approval is for Oxybutynin hydrochloride 2.5mg per 5ml Oral Solution, a drug used in the treatment of overactive bladder symptoms.

This development marks another major milestone for the company’s ongoing effort to expand in regulated international markets.

About the Product

Oxybutynin hydrochloride is a widely prescribed medication to manage symptoms such as frequent urination, urinary urgency, and urge incontinence. The oral solution format approved offers flexible dosing and is particularly suitable for paediatric and elderly patients or those unable to take solid dosage forms.

Strategic Significance of UKMHRA Approval

The UKMHRA is among the most respected regulatory authorities globally. Approval from this agency confirms that the drug adheres to strict safety, quality, and efficacy standards. For Marksans, this adds:

• A new dosage form to its urology segment

• Direct access to the UK prescription market

• Enhanced trust among healthcare providers and pharmacists

Strengthening Global Presence

Marksans Pharma is already known for its strong presence across multiple regulated markets including the United States, United Kingdom, and Australia. This approval further strengthens its portfolio in the European Union and positions Relonchem as a key driver of its European business.

Relonchem Limited, based in the United Kingdom, has been instrumental in regulatory filings, drug manufacturing, and marketing across the UK and EU. With the addition of this new product, the company’s presence in the oral solution segment expands further.

Company Overview: Marksans Pharma Ltd

Marksans Pharma is an Indian pharmaceutical company engaged in the research, manufacturing, and marketing of generic formulations globally. Its product categories cover major therapeutic areas, including:

• Cardiovascular system (CVS)

• Central nervous system (CNS)

• Anti-diabetics

• Pain management

• Gastroenterology

• Anti-allergy medications

Its manufacturing facilities are located in India, USA, and the UK and are approved by USFDA, UKMHRA, and Australian TGA.

Manufacturing and Regulatory Strength

The company’s manufacturing units are built to comply with international GMP standards. Facilities are routinely inspected by global regulatory authorities and have passed multiple inspections without major observations.

This gives Marksans the ability to launch drugs rapidly in new markets after obtaining approvals. In the case of Oxybutynin hydrochloride, the approval by UKMHRA proves its ability to manage the full lifecycle from R&D to regulatory clearance and commercial launch.

UK Market and Expansion Strategy

The UK market is considered a strategic market for generic formulations due to:

• Stable pricing via the NHS

• Clear regulatory pathways

• High acceptance of Indian pharmaceutical exports

By securing approval for a drug in liquid form, Marksans not only expands its portfolio but also meets demand for alternative dosage forms, especially useful in niche therapeutic areas.

The Competitive Edge

This development strengthens Marksans’ competitive edge in:

• Specialty dosage forms like liquids, softgels, and suspensions

• Paediatric and geriatric care segments

• Global contract development and manufacturing organisation (CDMO) opportunities

With Oxybutynin hydrochloride oral solution now approved, Marksans can explore partnerships or distribution tie-ups across the UK and potentially enter mutual recognition pathways for broader European access.

Recent Developments and Future Outlook

Marksans has consistently invested in:

• New product filings across USFDA, UKMHRA, and TGA

• Capacity expansions in its Goa and UK facilities

• Building out its US generics portfolio with complex generics and soft gel capsules

Future plans include:

• Targeting more UKMHRA approvals in 2025

• Growing share in European pharmacy chains

• Introducing digital pharmacovigilance and AI in drug development

The Oxybutynin approval is just one of several expected UK filings to be cleared in this calendar year.

Conclusion

With the UKMHRA approval of Oxybutynin hydrochloride 2.5mg per 5ml Oral Solution, Marksans Pharma demonstrates its global capabilities, regulatory compliance, and commitment to affordable healthcare.

The company is well-positioned to deliver value in key therapeutic categories and maintain strong growth in regulated markets through its robust pipeline and international quality standards.

Marksans continues to fulfil its mission of delivering safe, effective, and affordable medicines to millions around the world.

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