Laborate Pharmaceuticals has recently announced a significant milestone with its manufacturing facility in India, receiving the prestigious EU-GMP (European Union – Good Manufacturing Practice) certification from the relevant European regulatory body. This certification represents a recognition of the facility’s adherence to the rigorous quality standards mandated by the EU for pharmaceutical manufacturing. It signifies a crucial advancement for Laborate Pharma, enabling the company to broaden its export capabilities into the European Union and other regulated markets. The manufacturing site specializes in Oral Solid Dosage Form production, encompassing Tablets & Capsules, and boasts cutting-edge technology and processes to ensure consistent quality and regulatory compliance.
Parag Bhatia, the Director of Laborate Pharmaceuticals, emphasized the significance of this EU-GMP certification in affirming the company’s commitment to upholding superior quality standards and manufacturing practices. This achievement positions Laborate Pharma as an EU-GMP accredited pharmaceutical entity, furthering its ability to deliver safe and effective medications to a global consumer base. The certification opens doors for the company to engage in promising collaborations with clientele in Europe and the UK for the joint development and supply of formulated products aimed at treating diverse medical conditions, thereby driving Laborate’s international growth strategy and product portfolio expansion in the coming years.
The EU-GMP-certified facility, spanning an area of 157,500 square feet and featuring dedicated zones for various production stages, underwent a meticulous evaluation process covering its operational procedures, documentation standards, and quality management protocols to secure the certification. This milestone not only facilitates the facility’s entry into the EU market but also streamlines the regulatory dossier filing process for multiple products, with plans to submit 20 dossiers within the next five months for approvals across Europe, the UK, Australia, and South Africa. Moreover, Laborate Pharma is actively exploring additional certifications from authorities like GCC and EAEU to strengthen its foothold in regulated markets and bolster its global presence.
Parag Bhatia reiterated the company’s strategic focus on establishing enduring partnerships with global entities that prioritize dependable and scalable manufacturing solutions while ensuring cost-effectiveness and compliance with regulatory standards. The EU-GMP certification not only enhances Laborate Pharma’s credibility as a trusted pharmaceutical manufacturer but also positions it as a key player in the global pharmaceutical landscape, poised for sustainable growth and innovation in the years ahead.
– Laborate Pharmaceuticals achieves EU-GMP certification, marking a significant milestone in its global expansion journey.
– The certification enables Laborate Pharma to export products to the EU and other regulated markets, fostering international collaborations and market access.
– The company plans to file 20 regulatory dossiers in the EU, UK, Australia, and South Africa, showcasing its commitment to expanding its product portfolio globally.
– Laborate Pharma’s focus on establishing long-term partnerships underscores its dedication to reliable, cost-effective, and compliant manufacturing practices.
Tags: formulation, regulatory
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