Regulatory Milestone: Marksans Pharma’s UK Arm Secures MHRA Nod For Moxonidine Tablets

Marksans Pharma Ltd has achieved a significant regulatory breakthrough with its UK-based subsidiary, Relonchem Ltd, receiving marketing authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) for Moxonidine tablets. The approval, granted in September 2025, covers multiple dosage strengths and marks a strategic expansion of the company’s cardiovascular portfolio in the UK market.

 

The authorization enables Relonchem to commercialize Moxonidine, a centrally acting antihypertensive agent, across retail and institutional channels. The development is expected to enhance Marksans Pharma’s footprint in Europe and contribute to its growing export revenues.

 

Key Highlights From The Authorization

 

- MHRA grants marketing authorization for Moxonidine tablets to Relonchem Ltd  

- Approved strengths include 200 mcg, 300 mcg, and 400 mcg film-coated tablets  

- Authorization supports UK-wide distribution through pharmacies and hospitals  

- Marksans Pharma shares rose over 3 percent following the announcement  

- The approval complements existing cardiovascular and CNS product lines  

 

Therapeutic Relevance And Market Potential

 

Moxonidine is prescribed for the treatment of essential hypertension and is known for its favorable side-effect profile compared to older antihypertensive agents. It acts on imidazoline receptors in the brainstem to reduce sympathetic nervous system activity, thereby lowering blood pressure.

 

The UK market for antihypertensive drugs remains robust, driven by:

 

- Rising prevalence of lifestyle-related cardiovascular conditions  

- Aging population with increased demand for chronic care medications  

- Preference for generic alternatives amid NHS cost containment efforts  

 

Relonchem’s entry with Moxonidine is expected to offer a competitively priced option for prescribers and patients, while strengthening the company’s therapeutic presence in the cardiovascular segment.

 

Regulatory Pathway And Product Details

 

The MHRA authorization follows a rigorous review of clinical data, manufacturing standards, and pharmacovigilance protocols. The approved formulations include:

 

- Moxonidine 200 microgram film-coated tablets  

- Moxonidine 300 microgram film-coated tablets  

- Moxonidine 400 microgram film-coated tablets  

 

These products will be manufactured at Marksans Pharma’s UK facility, which is already approved by leading global regulators including the USFDA, UK MHRA, and Australian TGA. The tablets are expected to be launched under the Relonchem label, with distribution through established pharmacy networks and hospital procurement channels.

 

Stock Performance And Investor Sentiment

 

Following the announcement, Marksans Pharma shares gained 3.37 percent intraday, reaching Rs 184.60 on the National Stock Exchange. The stock has shown consistent upward momentum in recent months, supported by strong export performance and regulatory wins.

 

Investor interest is being driven by:

 

- Expansion of high-margin product lines in regulated markets  

- Strengthening of UK and EU operations post-Brexit  

- Diversification across therapeutic areas including CNS, CVS, and anti-diabetics  

- Robust compliance track record and manufacturing scalability  

 

Strategic Outlook And Global Expansion

 

The MHRA approval for Moxonidine is part of Marksans Pharma’s broader strategy to deepen its presence in regulated markets through its subsidiaries in the UK and US. The company has been actively filing new drug applications and expanding its product basket to include both prescription and over-the-counter formulations.

 

Future initiatives include:

 

- Launch of additional cardiovascular and CNS drugs in Europe  

- Expansion of manufacturing capacity at UK and Goa facilities  

- Strengthening of regulatory affairs and pharmacovigilance teams  

- Exploration of co-marketing and licensing partnerships in new geographies  

 

Regulatory Pulse

 

Marksans Pharma’s latest MHRA nod reinforces its position as a reliable supplier of high-quality generics in the UK. As regulatory agencies worldwide tighten standards for drug approvals, the company’s ability to meet compliance benchmarks and deliver timely filings will be key to sustaining its growth trajectory.

 

Sources: Business Standard, MHRA Product Database, GOV.UK Marketing Authorisations List.