9
Manufacturing sites
Regulatory Authorizations & GMP Certifications
Unither Pharmaceuticals operates under some of the world’s most stringent regulatory frameworks. Across our 9 global manufacturing sites, we hold authorizations from over 15 national and international agencies — including the FDA, EMA, ANVISA, MHRA, and Health Canada — underpinning every product we manufacture for our partners.
15+
Regulatory agencies
4
Continents
ISO 13485
Certified sites
A global compliance infrastructure built for CDMO partnerships
When pharmaceutical companies choose a contract development and manufacturing organisation (CDMO), regulatory standing is non-negotiable. Unither’s multi-site authorization network means partners can target virtually any global market — from the United States and Europe to Brazil, South Korea, Australia, and beyond — without switching manufacturing partners.
Each Unither site maintains its own regulatory dossier, renewed through regular agency inspections. Our quality teams work proactively with clients to prepare submission-ready documentation, manage agency queries, and support post-approval change management.
In addition to market authorizations, our sites hold internationally recognized quality standards including European cGMP, FDA cGMP, ISO 13485:2016 for medical devices, ISO 50001 for energy management, and Good Laboratory Practice (GLP) certification.
FDA-approved manufacturing
Rochester (USA) site authorized for sterile & non-sterile production under FDA cGMP and DEA regulations
EMA-authorized European sites
Amiens, Coutances, Bordeaux, Gannat & Colomiers operate under European cGMP with full ANSM oversight
ISO 13485 medical device certification
Multiple sites GMED/LNE certified under ISO 13485:2016 for pharmaceutical medical device manufacturing
ANVISA & Latin American coverage
Brazil sites authorized by ANVISA; additional coverage in Colombia (INVIMA), Peru (DIGEMID), and Pakistan (DRAP)
Full authorization & certification matrix
The table below details the regulatory authorizations and quality certifications held by each Unither manufacturing site. Data is maintained in line with the latest agency inspection outcomes.
Regulatory authorizations and GMP certifications held by each Unither Pharmaceuticals manufacturing site worldwide :
|
Site |
Regulatory Authorizations |
Standards & Certifications |
|
Butantã BR |
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Barretos BR |
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Amiens FR |
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Coutances FR |
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Bordeaux FR |
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Gannat FR |
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Colomiers FR |
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Rochester USA |
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Nanjing CN |
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Compliance
European GMP & EMA authorization
Five of Unither’s French sites operate under European cGMP, the mandatory quality standard for pharmaceutical manufacturers supplying the EU market. EMA authorization confirms these sites meet the highest standards for sterile and non-sterile production, making them eligible for inclusion in European Marketing Authorisation Applications (MAAs).
FDA cGMP — US market access
Unither’s Rochester (USA) facility and Coutances (France) site both hold FDA authorization, enabling clients to manufacture products for the US market at either location. Our FDA-approved sites have successfully passed both sterile and non-sterile facility inspections and operate under 21 CFR Part 211 current Good Manufacturing Practice regulations.
ISO 13485:2016 — Medical device manufacturing
Several Unither sites hold ISO 13485:2016 certification through GMED and LNE, the internationally recognised standard for quality management systems in medical device manufacturing. This certification is essential for combination products and pharmaceutical medical devices, covering design, development, and production processes.
ANVISA — Latin American market coverage
Unither’s Brazilian sites in Butantã and Barretos are both authorized by ANVISA, Brazil’s National Health Surveillance Agency. Combined with INVIMA (Colombia) and DIGEMID (Peru) authorizations, Unither offers one of the most comprehensive Latin American regulatory footprints among European CDMOs.
Manufacturing sites
Regulatory & compliance FAQs
Which Unither sites are FDA-approved for manufacturing?
Unither’s Rochester (USA) site holds primary FDA and DEA authorization. The Coutances (France) site also holds FDA authorization, enabling clients to manufacture FDA-regulated products in Europe — a strategic advantage for multi-market launches.
Does Unither hold ISO 13485 certification for medical devices?
Yes. Multiple sites — including Amiens, Coutances, Gannat, Colomiers, and Nanjing — are certified to ISO 13485:2016 for medical device quality management systems, verified by GMED and LNE notified bodies.
Can Unither manufacture for the Brazilian market?
Yes. Unither has two ANVISA-authorized sites in Brazil (Butantã and Barretos), and several European sites also hold ANVISA authorization — offering flexible manufacturing options for partners targeting the Brazilian pharmaceutical market.
How do I know which site is right for my product?
Site selection depends on your target markets, dosage form, and development stage. Our business development team provides a site-matching assessment based on your regulatory dossier requirements. Contact us to discuss your project.