Pharmaceutical cGMP Commercial Manufacturing for Oral Solid Dose
When your product is ready for scale-up to commercial manufacturing or you are looking to qualify a secondary manufacturing source, Recro® provides a structured approach to technology transfer, managing the smooth transition of all relevant product, process, and method knowledge. Our front-end planning and skilled project management help you avoid unanticipated costs and delays.
Key Benefits of Working With Recro for Commercial Pharmaceutical Manufacturing
Speed, Flexibility, and Responsiveness
At Recro, we pride ourselves on being easy to work with. Streamlined intake processes and ongoing effective and efficient communications add up to a frictionless experience. You can rely on our competent technical team to meet and exceed your expectations for delivering commercial-scale products without any fuss.
Clients know that once they hand their project over to Recro, it’s going to be managed completely, which is great because they have other things to do than micromanage their CDMOs.”
Industry Experience and Leadership in Pharmaceutical Manufacturing and Regulatory Affairs
We offer you 30 years of experience in commercial manufacturing at Recro. We are experts in all aspects of cGMP manufacturing, from technical transfer to processing to analytical testing to regulatory compliance, and we will approach your project with practical solutions in mind.
On-Time Delivery and a Right-First-Time Focus on Quality
For our clients, peace of mind means confidence in timelines and impeccable product quality. An aggressive right-first-time quality assurance program is just one of the ways we provide that peace of mind. Our sites consistently achieve a high level of compliance and have a proven track record with the FDA, foreign health ministries, the DEA, and our clients.
Broad Analytical Testing Capabilities
As part of our focus on safety and quality, we offer extensive analytical quality control options for commercial manufacturing. These capabilities are above and beyond what you might expect for a midsize CDMO.
Quality is critical to a successful product, and Recro has this embedded in our culture. With Recro’s stellar history with the FDA and other regulatory agencies, you can depend on us to assure compliance.”
Sherida Vandiver, Vice President Quality
Enhanced, Cost-Effective Manufacturing Capabilities — and Wide-Ranging Capacity
Our key technologies include:
- Roller compaction
- Spray granulation
- Rotary granulation
- Particle/bead coating
- Tablet coating
For comprehensive details on:
- Capabilities, Concept Through Commercialization
- Analytical Equipment
- Process Equipment
- Scale and Capacity
- Compliance History
- Facilities, Including cGMP
Commercial Packaging and Logistics: Leverage the Efficiencies of a Single Provider
Maintain the safety and integrity of your pharmaceutical products with Recro’s convenient contract packaging and logistics solutions:
- Primary and secondary packaging
- DSCSA-compliant serialization services
- Reliable and timely shipping
Talk to Our Experts
Take Your Manufacturing to the Next Level
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