Services
Learn more about what Agno Pharmaceuticals can do to help you accomplish your goals.
Client Technology Integration
Hard-to-Manufacture and Low-Availability APIs
New Chemical Entities (NCEs) Development
Regulatory Compliance and Qualification
Generic API Supply
Collaborative Partnering
Our Expertise
Our expertise encompasses integrating Client Provided chemistry, where we seamlessly incorporate your proprietary processes into our manufacturing operations. We excel in the development and production of New Chemical Entities (NCEs), ensuring cutting-edge innovation and quality. We specialize in Specialty APIs, addressing the unique and complex requirements of niche therapeutic areas. With Agno Pharma, you gain a dedicated partner committed to advancing your projects with precision and excellence. Our capabilities extend to Generic APIs, providing cost-effective solutions without compromising on efficacy.
Additional Services
At Agno Pharma, we specialize in seamlessly incorporating client-provided technology into our cGMP API manufacturing processes. Our approach ensures that your proprietary technology transitions smoothly to our cGMP production and is supported by rigorous qualification procedures to guarantee compliance and performance. This integration process is carefully managed to align with industry standards and regulatory requirements, ensuring a seamless fit with our existing manufacturing systems.
For biotech and pharmaceutical companies focused on developing new chemical entities (NCEs), Agno Pharma offers extensive expertise in advancing these innovations from concept to market. We understand the complexities involved and provide robust support to both small biotech firms and larger pharmaceutical companies. Our commitment to strict confidentiality and intellectual property protection means that your sensitive information and innovations are safeguarded throughout the development proces. As a US company we hold ourselves to the highest legal standards.
We pride ourselves on our efficiency and adherence to project timelines, demonstrating flexibility and responsiveness to meet your specific needs and milestones. Our goal is to facilitate the successful market entry of your NCEs, delivering high-quality results on schedule.
In addition to our work with NCEs, Agno Pharma is a trusted supplier of generic APIs, partnering with Market Authorization Holders to deliver a diverse range of products.
Our portfolio includes both common and challenging APIs, with some available through exclusive US marketing partnerships. We are engaged in numerous client-specific projects involving hard-to-manufacture and low-availability APIs, reflecting our dedication to meeting complex demands and providing high-quality solutions. Our expertise in these areas underscores our commitment to fostering strong, collaborative relationships with our partners while addressing the unique challenges of each project.
| non-HP API | cannabidiol (CBD) |
| cefiderocol | |
| ceftolozane | |
| indomethacin | |
| sulindac | |
| isosulfan Blue | |
| HPAPI | carmustine |
| paclitaxel* | |
| Sterile API | aripiprazole lauroxil |
| aripiprazole monohydrate | |
| avibactam | |
| ceftaroline fosamil | |
| ceftobiprole medocaril | |
| cyclophosphamide | |
| mannitol* | |
| paliperidone Palmitate |
* mutual exclusive US marketing partnership established
Agno Pharma has extensive experience in the development, validation and commercial manufacture of specialty APIs. Our scientists, production operators, EH&S and related functions are well-trained and experienced in the safe handling of such materials. State-of-the-art containment systems (isolators, butterfly valves, filters) are used and proper segregation, isolation, and cleaning principles are incorporated during the process development and codified into SOPs, batch records and other documents.
- beta-lactams (β-lactams) including penicillin derivatives
- steroids and hormones
- cytotoxic compounds