Navinta LLC
Navinta, LLC is a privately held generic pharmaceutical company founded in 2003. The company develops and commercializes generic and specialty pharmaceutical products, maintains active Drug Master Files (DMFs), pursues regulatory submissions (ANDA, 505(b)(2)/NDA, device applications), and conducts internal R&D focused on complex formulations, novel delivery systems, and API chemical processes. Navinta operates cGMP manufacturing activities including sterile injectable production and manages global supply chain and contract manufacturing relationships.
Industries
Nr. of Employees
small (1-50)
Patents
Direct compression and dry granulation processes for preparing carglumic acid tablets having less impurities than those produced by wet granulation process
US-10064826-B2
View Details
Direct compression and dry granulation processes for preparing carglumic acid tablets having less impurities than those produced by wet granulation process
US-10064826-B2
View DetailsProducts
Commercial generic pharmaceutical products (ANDA-approved)
Commercialized generic medicines across multiple therapeutic areas brought to market via ANDA approvals.
Active Drug Master Files (DMFs)
Management of multiple active DMFs for APIs to support regulatory submissions.
Commercial generic pharmaceutical products (ANDA-approved)
Commercialized generic medicines across multiple therapeutic areas brought to market via ANDA approvals.
Active Drug Master Files (DMFs)
Management of multiple active DMFs for APIs to support regulatory submissions.
Services
Development of generic and specialty formulations with regulatory filing support for ANDA and 505(b)(2)/NDA pathways.
cGMP production of finished dosage forms and APIs, coordination with qualified CMOs, and serialization for distribution.
Chemical process R&D for APIs including cytotoxic and polymer-chemistry APIs and preparation/maintenance of Drug Master Files.
Microbiology lab testing, environmental monitoring, sterility testing, endotoxin testing, particulate and water analysis, and media fill execution.
Development of generic and specialty formulations with regulatory filing support for ANDA and 505(b)(2)/NDA pathways.
cGMP production of finished dosage forms and APIs, coordination with qualified CMOs, and serialization for distribution.
Chemical process R&D for APIs including cytotoxic and polymer-chemistry APIs and preparation/maintenance of Drug Master Files.
Microbiology lab testing, environmental monitoring, sterility testing, endotoxin testing, particulate and water analysis, and media fill execution.
Expertise Areas
- Generic pharmaceutical development and commercialization
- cGMP manufacturing for sterile and oral dosage forms
- Formulation development and novel delivery systems
- API chemical process development and scale-up
Key Technologies
- Lyophilization (freeze-dried injectables)
- Sterile fill-finish operations
- Oral solid dosage formulation (tablets, capsules)
- Spray/alternate-route delivery systems
News & Updates
Company referenced FDA approval for an ANDA application.
Company referenced FDA approval for an ANDA application.
Company referenced FDA approval for an ANDA application.
Company referenced FDA approval for an ANDA application.
Company referenced FDA approval for an ANDA application.
Company referenced FDA approval for an ANDA application.
Company referenced FDA approval for an ANDA application.
Company referenced FDA approval for an ANDA application.