Laborate Pharmaceuticals has announced that its oral solid dosage manufacturing site has received the European Union – Good Manufacturing Practice (EU-GMP) certification from the relevant European regulatory agency. The approval permits the company to export its pharmaceutical products to the European Union and other regulated markets.
The facility, located in India, is designed for oral solid dosage forms, including tablets and capsules. It has been fitted with systems and processes that meet EU standards for quality and regulatory compliance. The manufacturing unit covers 157,500 square feet, with dedicated areas spanning 53,000 square feet. The certification followed an audit that examined the site’s documentation, processes, systems, and quality management standards.
“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 Pharmaceuticals is currently in advanced discussions with clients in Europe and the United Kingdom for the co-development and supply of finished formulation products intended to treat various therapeutic conditions. These potential agreements are expected to support the company’s international strategy and product pipeline over the next five years.
Following the certification, the company plans to file 20 regulatory dossiers over the next five months for products to be launched in Europe, the UK, Australia, and South Africa. The company is also exploring further certifications through regulatory bodies such as the Gulf Cooperation Council (GCC) and the Eurasian Economic Union (EAEU).
“We are focused on establishing longer-term partnerships with global companies that value reliable and scalable manufacturing at a cost-effective and compliant basis,” Bhatia added.