OUR EXPERTISE

CDMO

Manufacturing solutions end to end - under one roof

With more than 30 years of experience in developing and manufacturing complex oral and semi-solid formulations, we support partners across the full life cycle of pharmaceutical production — from clinical batches to global commercial supply.

Our manufacturing operations are built for flexibility, quality, and speed. We take a responsive, collaborative approach to every project, helping partners meet critical timelines without compromising on compliance or product integrity.

Authorized by major global regulatory bodies, our facilities operate to the highest standards of quality, delivering consistent, reliable outcomes for customers and the patients they serve.

Range of services

1

Manufacturing Process Expertise

Extensive experience in developing and assessing manufacturing processes for pharmaceutical products, built over 30+ years. Capabilities include solid, semi-solid, and liquid oral dosage forms, including tablet and film coating technologies.

2

Technology Transfer & Product Stability

Support for technology transfer to ensure seamless scale-up and consistent product quality. Evaluation of pharmaceutical product stability to meet regulatory and quality requirements.

3

Product Testing, Release & Registration Support

In-house quality control laboratories performing rigorous testing in compliance with GMP standards. Preparation and drafting of comprehensive documentation to support pharmaceutical product registration worldwide.

4

Regulatory Approvals and Compliance

Authorized by multiple global regulatory authorities including FDA (USA), AIFA (Italy), PMDA (Japan), ANVISA (Brazil), and Russian Health Authority. Quality system certified to ISO 13485 standard, emphasizing continuous improvement and customer satisfaction.

5

State-of-the-Art Manufacturing Facility

A dedicated 18,000 m² production plant located in Lainate, equipped with seven production departments supporting wet and dry granulation, tableting, film coating, and clinical batch preparation. Serialization and aggregation systems implemented to satisfy global pharmaceutical product traceability requirements.

6

Quality Assurance & Control

Quality department encompassing quality control labs, validation, and regulatory affairs units, ensuring adherence to SOPs and GMP compliance. Use of validated, cutting-edge analytical instrumentation compliant with EU GMP Annex 11 and FDA 21 CFR Part 11 to guarantee data accuracy and integrity.

7

Business Continuity & Capacity

Ensured business continuity through backup facilities and expanded production capabilities to meet client needs effectively.

Get in touch

Get in touch to enquire about our services
or a prospective partnership.

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