Novocol, Inc.
Novocol Pharma is a global leader in providing integrated turnkey cartridge manufacturing and innovative drug delivery solutions, serving biopharma customers from development to patient. As part of the Septodont Group, it emphasizes personalized, responsive CDMO services with a focus on quality, integrity, and value. The company specializes in sterile injectable products, drug development, analytical services, and medical device innovation, supporting customers worldwide with a broad range of manufacturing capabilities and regulatory compliance.
Industries
Nr. of Employees
large (251-1000)
Products
Cartridges (bulk and RTU)
Sterile injectable cartridges produced in bulk or as ready-to-use (RTU) formats across multiple fill volumes and ranges.
Ready-to-use vials
Sterile ready-to-use vials in multiple R sizes for clinical and commercial use.
Pre‑filled syringes (RTU)
Ready-to-use pre-filled syringes for injectable therapies with supported fill volumes suitable for clinical and commercial supply.
Microvials / unit-dose vials
Unit-dose and bi-dose microvials for unit-dose delivery needs.
Cartridges (bulk and RTU)
Sterile injectable cartridges produced in bulk or as ready-to-use (RTU) formats across multiple fill volumes and ranges.
Ready-to-use vials
Sterile ready-to-use vials in multiple R sizes for clinical and commercial use.
Pre‑filled syringes (RTU)
Ready-to-use pre-filled syringes for injectable therapies with supported fill volumes suitable for clinical and commercial supply.
Microvials / unit-dose vials
Unit-dose and bi-dose microvials for unit-dose delivery needs.
Services
Aseptic and terminal fill–finish for cartridges, vials, pre-filled syringes and microvials with cGMP operations, automated inspection, packaging and cold chain support.
Integrated assembly of drug products with delivery devices including specification, procurement and validation of assembly lines, labelling, tertiary packaging, serialization and aggregation.
Formulation and process development, scalability and technology transfer, analytical method development and validation, cleaning method validation, extractables & leachables, and stability testing.
Design and development services for drug delivery devices, including engineering, regulatory affairs support, manufacturing planning and project management.
Regulatory registration support across major markets, preparation of CMC packages in eCTD format, lifecycle management and quality system compliance (ISO 13485).
Automated labelling, blistering and packaging lines with serialization and aggregation capabilities, plus cold chain and ambient storage logistics.
Aseptic and terminal fill–finish for cartridges, vials, pre-filled syringes and microvials with cGMP operations, automated inspection, packaging and cold chain support.
Integrated assembly of drug products with delivery devices including specification, procurement and validation of assembly lines, labelling, tertiary packaging, serialization and aggregation.
Formulation and process development, scalability and technology transfer, analytical method development and validation, cleaning method validation, extractables & leachables, and stability testing.
Design and development services for drug delivery devices, including engineering, regulatory affairs support, manufacturing planning and project management.
Regulatory registration support across major markets, preparation of CMC packages in eCTD format, lifecycle management and quality system compliance (ISO 13485).
Automated labelling, blistering and packaging lines with serialization and aggregation capabilities, plus cold chain and ambient storage logistics.
Expertise Areas
- Sterile injectable manufacturing
- Combination product assembly (drug + device)
- Drug delivery device design and engineering
- Formulation and process development for injectables
Key Technologies
- Aseptic filling (ISO 5 cleanrooms)
- Terminal sterilization in controlled environments (ISO 7)
- HPAPI containment systems (0.01 µg/m3 capability)
- Automated visual inspection systems
News & Updates
Participation in CPHI Frankfurt 2022, showcasing capabilities and exploring partnerships.
Participation in BIO International Convention, connecting with biotech leaders.
Participation in CPhI's virtual event, showcasing CDMO services.
Participation in BIO Digital Event, highlighting innovation and partnerships.
Participation in CPHI Frankfurt 2022, showcasing capabilities and exploring partnerships.
Participation in BIO International Convention, connecting with biotech leaders.
Participation in CPhI's virtual event, showcasing CDMO services.
Participation in BIO Digital Event, highlighting innovation and partnerships.