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Laborate Pharmaceuticals Achieves EU-GMP Certification for Its Himachal Pradesh Manufacturing Facility

07 Aug 2025
Admin
News Article

Laborate Pharmaceuticals Achieves EU-GMP Certification for Its Himachal Pradesh Manufacturing Facility

Laborate Pharmaceuticals, a key player in India’s pharmaceutical export ecosystem, has received EU-GMP certification for its oral solid dosage manufacturing site at Paonta Sahib, Himachal Pradesh. This marks a significant milestone for the company as it prepares to scale its presence across Europe and other regulated markets.

What the Certification Means

EU-GMP (European Union - Good Manufacturing Practice) is one of the most stringent regulatory certifications for pharmaceutical manufacturers.
The certification validates compliance with EU standards for manufacturing quality, safety, and documentation.
It opens direct pathways for product registration and supply to EU, UK, Australia, and South Africa, with 20 regulatory dossiers planned for submission within the next 5 months.

Facility Highlights

Total Area: 157,500 sq. ft.
Dedicated manufacturing space: 53,000 sq. ft.
Dosage forms: Tablets and Capsules
Infrastructure: Equipped with state-of-the-art systems for precision manufacturing, QMS, and documentation.

Strategic Expansion Plans

Laborate is in advanced talks with European and UK clients for the co-development and supply of finished formulations across therapeutic categories.
The company is also pursuing certifications from GCC, EAEU, and other global authorities to expand its footprint in regulated markets.
Focus therapeutic areas: Cardiovascular, Diabetes, Pain Management, CNS, and other general segments.

Leadership Commentary

“This certification is not just a badge—it’s a foundation for expanding our regulated market presence. We’re building global partnerships based on quality, scalability, and compliance,”

Parag Bhatia, Director, Laborate Pharmaceuticals

Why It Matters

With this EU-GMP nod, Laborate joins a growing list of Indian manufacturers poised to meet global quality benchmarks. The certification not only reinforces its credibility but also adds momentum to India’s export-driven pharma manufacturing model.

Track EU-GMP certified sites, upcoming dossier filings, and regulatory pipelines from India’s top pharma exporters.