Compare CDMOs with sterile injectable manufacturing capabilities. Filter by container type, aseptic technology, and regulatory approvals.
283 companies listed
Sterile injectable manufacturing produces parenteral drug products -- formulations administered by injection (intravenous, subcutaneous, intramuscular, intrathecal). These products require the highest level of manufacturing control because they bypass the body's natural defense barriers. Any microbial, particulate, or endotoxin contamination can be life-threatening.
The sterile injectable market is growing faster than overall pharma, driven by biologics (monoclonal antibodies, ADCs), specialty injectables (long-acting formulations, complex generics), and the shift toward self-administered subcutaneous products. Capacity remains constrained globally, with lead times of 12-24 months at many CDMOs.
Japan
Bushu Pharma is Japan's premier CDMO with over 25 years of experience, specializing in contract manufacturing of solid dosage formulations, sterile injectables, lyophilized products, and prefilled syringes for both clinical trial supplies and commercial products. The company operates five factories in Japan with GMP certifications from 56 countries including FDA, EMA, and PMDA, serving over 90 pharmaceutical companies globally with nearly 50% of sales from foreign-affiliated clients.
India
Caplin Point Laboratories is a fully integrated Indian pharmaceutical company with a dominant presence in Latin America and Francophone Africa, and a growing presence in the US and EU. Through its subsidiary Caplin Steriles, the company manufactures sterile injectables, ophthalmic products, pre-mix bags, and pre-filled syringes, with 46 FDA-approved products.
Our AI Matchmaker analyzes your project requirements and matches you with qualified manufacturing partners. Free for buyers.