Laborate Pharma secures EU-GMP certification, expands global supply chain capabilities

"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."

Laborate is currently negotiating advanced discussions with clients in Europe and UK for the co-development and supply of finished formulation products targeted to treat various therapeutic diseases. These agreements will play a key role in Laborate's international strategy, pipeline expansion over the next 5 years.

The EU-GMP-certified facility, covering 157,500 square feet, has dedicated areas for 53000. The facility was audited and certified after a detailed investigation of its processes, systems, documentation, and quality management systems.

In fact, 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 5 months to obtain approvals in Europe, 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 Parag Bhatia, Director, Laborate Pharmaceuticals.