Laborate Pharmaceuticals has announced that its state-of-the-art manufacturing facility in Paonta Sahib, Himachal Pradesh, has been awarded the EU-GMP (European Union - Good Manufacturing Practice) certification by the relevant European regulatory authority.

This recognition confirms the facility's compliance with the high standards set by the EU for pharmaceutical manufacturers, providing Laborate with new opportunities to export and ship its products to the European Union and other regulated markets.

Established in 2010, the Paonta Sahib site is the third and largest manufacturing unit of Laborate Pharmaceuticals. Designed and built in line with USFDA and EU-GMP standards, the facility is equipped with advanced technology and comprehensive quality systems to ensure consistent quality and regulatory compliance.

Covering 157,500 square feet, with 53,000 square feet of dedicated production areas, the facility is equipped for the manufacturing of a wide range of pharmaceutical products, including oral solid dosage forms (capsules and tablets), injectable (dry/liquid vials and ampoules), ophthalmic preparations, external applications (cream/ointments/gel/lotions), oral liquid, and dry syrups.

There are also separate manufacturing facilities for general products/beta-lactam products and cephalosporin products.  

According to the company, the facility was audited and certified after a detailed investigation of its processes, systems, documentation, and quality management systems.

"This EU-GMP certification provides a clear pathway to our focus on world-class standards of quality and manufacturing to take an unprecedented step to be recognised as the EU-GMP accredited pharmaceutical organisation," said Parag Bhatia, Director, Laborate Pharmaceuticals.

"The certification confirms our capability to supply and export quality, safe, and effective medicines to millions of people around the world,” he added.

With this certification, Laborate is now in advanced discussions with clients in Europe and the UK for the co-development and supply of finished formulation products targeted to treat various therapeutic diseases.  

These agreements are expected to play a key role in Laborate's international strategy, pipeline expansion over the next five years.

The facility certification provides a path to filing regulatory dossiers for multiple products in the EU market. The company intends to file 20 dossiers over the next five months to obtain approvals in Europe, the UK, Australia, and South Africa.   

The company is also exploring additional certifications via authorities such as GCC, EAEU to enhance its presence in regulated markets.  

"We are focused on establishing longer-term partnerships with global companies that value reliable and scalable manufacturing at a cost-effective and compliant basis," said Bhatia.

The company is projecting over USD 100M in international revenue growth over the next five years.

Founded in 1985, Laborate Pharmaceuticals offers a broad portfolio of therapeutic products across cardiovascular (CVS), diabetes, pain management, central nervous system (CNS), and general medicine categories. With a presence in over 55 countries, the company operates multiple cGMP-compliant facilities, certified by global regulatory agencies including WHO-GMP, and now EU-GMP.