Astrea
Astrea Pharma was founded with the purpose of building a world-class, customer-focused CDMO, dedicated to driving efficiency and value in the pharma supply chain while delivering quality, OTIF, and cost commitments to its customers. With over 75 years of combined experience, the company specializes in acquiring and developing manufacturing facilities, offering a broad range of technologies from Development to Commercial Supply, including finished dose OSD and Aseptic Manufacturing. Astrea emphasizes long-term partnerships, quality, continuous improvement, agility, transparency, and environmental responsibility, supporting clients across the entire product lifecycle and regulatory landscape.
Industries
Nr. of Employees
medium (51-250)
Patents
Services
Support for product lifecycle projects including reformulation, process optimization, analytical method development and validation, cost redesigns and packaging optimization.
Pre-formulation, formulation and drug product development from early to late-stage across OSD and sterile technologies, integrated with manufacturing capabilities.
Regulatory due diligence and strategy, preparation of marketing authorization applications (CP/DCP/MRP/NS), technical dossiers, supplements, post-marketing maintenance, eCTD compilation and authority response preparation.
Turnkey transfer services including gap assessments for regulatory, production and analytical readiness and implementation of product transfer into routine production or new sites.
Dedicated project management for technical projects, new product introductions and customer development programs with tailored delivery.
Support for product lifecycle projects including reformulation, process optimization, analytical method development and validation, cost redesigns and packaging optimization.
Pre-formulation, formulation and drug product development from early to late-stage across OSD and sterile technologies, integrated with manufacturing capabilities.
Regulatory due diligence and strategy, preparation of marketing authorization applications (CP/DCP/MRP/NS), technical dossiers, supplements, post-marketing maintenance, eCTD compilation and authority response preparation.
Turnkey transfer services including gap assessments for regulatory, production and analytical readiness and implementation of product transfer into routine production or new sites.
Dedicated project management for technical projects, new product introductions and customer development programs with tailored delivery.
Expertise Areas
- Oral solid dose manufacturing
- Aseptic filling and sterile manufacturing
- Analytical method development and stability testing
- Tech transfer and industrialization
Key Technologies
- Dry granulation (roller compaction)
- Wet granulation (horizontal and vertical)
- Spray granulation
- High-shear mixing and formulation (50–2000 L scale)