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Laborate Pharmaceuticals, one of India's prominent pharmaceutical manufacturing and exporting companies, has announced that its manufacturing site in Laborate Pharmaceuticals India Ltd, 111, Paonta Sahib, Himachal Pradesh (HP) has been granted the EU-GMP (European Union - Good Manufacturing Practice) certification from the relevant European regulatory agency.
The certification confirms compliance with the high standards set by the EU for pharmaceutical manufacturers and provides Laborate Pharmaceuticals with new opportunities to export and ship its products to the European Union and other regulated markets. The facility is built for oral solid dosage form, including tablets & capsules, and is fitted with state-of-the-art systems and processes to ensure consistent quality and regulatory compliance.
"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. The certification confirms our capability to supply and export quality, safe and effective medicines to millions of people around the world," said Parag Bhatia, director, Laborate Pharmaceuticals.
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 53,000. The facility was audited and certified after a detailed investigation of its processes, systems, documentation, and quality management systems.
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 Bhatia.
Founded in 1985, Laborate Pharmaceuticals is one of the leading pharmaceutical companies in India, with capabilities in manufacturing, R&D, and global distribution. The company provides pharmaceutical products in therapeutic categories that include CVS, diabetics, pain management, CNS, and other general categories, and has presence in 55 countries worldwide.
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