Diabetes Care Revolution: Marksans Pharma Wins UK Approval for Innovative Metformin Solution

Marksans Pharma Ltd. has achieved a significant regulatory milestone, with its manufacturing unit receiving marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Metformin Hydrochloride Oral Solution. This green light marks a strategic expansion of Marksans’ diabetes care offerings in the UK, targeting patients who require liquid formulations for better compliance and dosing flexibility.

 

Key Highlights:

 

The newly approved Metformin Hydrochloride 500 mg/5 ml Oral Solution is indicated for the management of type 2 diabetes mellitus, especially in overweight adults and children aged 10 years and above, where diet and exercise alone do not provide adequate glycemic control.

 

The authorization allows the product to be used as monotherapy or in combination with other oral antidiabetic agents or insulin, broadening its clinical utility for healthcare providers and patients.

 

The MHRA’s approval follows a comprehensive benefit-risk assessment, concluding that the advantages of this oral solution formulation outweigh any potential risks. The decision was supported by a robust risk management plan and inclusion of safety information in the product’s summary of characteristics and patient leaflet.

 

Marksans’ UK manufacturing operations, recognized for their regulatory compliance, will produce the oral solution, further strengthening the company’s presence in the UK pharmaceutical market.

 

This development aligns with Marksans Pharma’s ongoing strategy to diversify its product portfolio and enhance its footprint in regulated markets, following previous approvals for other oral solutions and solid dosage forms.

 

With this latest approval, Marksans Pharma is poised to address unmet needs in diabetes management, offering a vital alternative for patients with swallowing difficulties or requiring precise dosing.

 

Sources: UK MHRA, Marksans Pharma, Business Standard