API Services
We aim to attain the status of a global leader for developing a novel route or non-infringing route for APIs.
Sambi Pharmaceutical’s API division, with their unique expert route scouting team, offers the development of novel synthetic routes or non-infringing routes for off-patent APIs. If customers are looking for off-patent APIs with competitive cost and quality, then our route scouting team can collaborate with customers to identify opportunities early and work closely with them to ensure timely availability of APIs to support their filings and ensure timely market entry.
Lab Services:
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- Synthesizing NCEs
- Library Synthesis for LI N LO Projects
- Our Business Model Includes FTE n FFS Hybrid Models, Long term Multiyear contract and continuous material supply support.
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Our Expertise in handling:
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- Heterocycles
- Chiral Chemistry – Chiron & Asymmetric synthesis
- Unnatural amino acids
- Small peptides: Solution phase up to hexamers
- Carbohydrates & Aza sugars
- Nucleoside building blocks
- PROTAC Chemistry
- ADC Linkers
- PEG- Lipids
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Analytical chemistry:
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- Data analysis & interpretation
- Method development & validation
- Reporting the results & documentation
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Quality Assurance and Quality Control:
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- At Sambi Pharma, utmost importance is given to Quality than business profits. With our quality culture across the company, we have built a remarkable reputation with clients.
- Every member of our team is equally committed to delivering zero-defect products on time, and as promised to our customers.
- The Principles of the Quality Management System adopted by the company are as per ISO 9001:2015 guidelines.
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Process R&D & Manufacturing:
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- Chemical Synthesis – Route proposal, Selection and Synthesis
- Process Development – Reaction optimization, Scale up studies, Product purification, Safety studies, Quality control, Process validation and Technology transfer.
- Scale up & Manufacturing: Synthesis of Advanced API intermediates and KSM (Key Starting Material) from KG-MT Scale.
- Loan licensed GMP/Non-GMP plants to offer commercial manufacturing activities.
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Our In- House Pilot Plant Includes:
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- 100 L 200 L 500 L glass reactor with Heating/cooling system: –70°C to +150°C
- 20 L high vacuum distillation unit
- Pressure Nutsche filter, centrifuge
- Autoclave ranging from 100ML – 25 L
- Rotavapors ranging from 2L – 20 L
- Vacuum Tray dryer
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Our Lab Images
Our Advantage
Sambi Pharmaceutical’s API team offer:
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- Novel synthetic route for off-patented APIs / APIs
- Non-infringing processes for off-patented APIs / APIs
- Process development of APIs
- Process validation of APIs
- Manufacture of APIs (GMP and non-GMP).
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Contact
4953 Vine Street
San Diego, CA 92465
815.555.5555
info@sambipharma.com