Navinta LLC
Navinta is a privately held pharmaceutical company established in 2003, dedicated to developing and commercializing medicines for chronic and life-threatening diseases. The company focuses on innovative formulations, complex products, and unique delivery systems, holding numerous patents and active drug master files. Navinta's mission is to transform ideas into technology and bring new medicines to the marketplace, emphasizing quality, innovation, and patient care.
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
Benztropine mesylate (injectable)
Injectable anticholinergic agent, 1 mg/mL.
Carmustine (injectable)
Injectable anticancer agent, 100 mg/vial.
Famotidine (oral suspension)
Oral suspension H2 antagonist, 40 mg/5 mL.
Fomepizole (injectable)
Injectable alcohol dehydrogenase inhibitor, 1.5 g/1.5 mL.
Fosaprepitant dimeglumine (injectable)
Injectable antiemetic equivalent to 150 mg base per vial.
Hydralazine hydrochloride (injectable)
Injectable antihypertensive vasodilator, 20 mg/mL.
Benztropine mesylate (injectable)
Injectable anticholinergic agent, 1 mg/mL.
Carmustine (injectable)
Injectable anticancer agent, 100 mg/vial.
Famotidine (oral suspension)
Oral suspension H2 antagonist, 40 mg/5 mL.
Fomepizole (injectable)
Injectable alcohol dehydrogenase inhibitor, 1.5 g/1.5 mL.
Fosaprepitant dimeglumine (injectable)
Injectable antiemetic equivalent to 150 mg base per vial.
Hydralazine hydrochloride (injectable)
Injectable antihypertensive vasodilator, 20 mg/mL.
Services
cGMP production of active pharmaceutical ingredients and controlled substances in a DEA-registered facility for clinical and commercial supply.
Development of oral solids, injectable solutions and lyophilized products, spray delivery systems, and alternate-route formulations.
Sourcing and management of qualified contract manufacturing organizations and coordination of product serialization for distribution.
Implementation of quality assurance programs, continuous improvement initiatives, and supplier performance management systems to ensure manufacturing quality.
Microbiological laboratory services including environmental monitoring, sterility testing, bacterial endotoxin testing, particulate matter testing, and water analysis.
Preparation and maintenance of Drug Master Files and support for regulatory submissions including ANDAs, 505(b)(2) NDAs, and device-related filings.
cGMP production of active pharmaceutical ingredients and controlled substances in a DEA-registered facility for clinical and commercial supply.
Development of oral solids, injectable solutions and lyophilized products, spray delivery systems, and alternate-route formulations.
Sourcing and management of qualified contract manufacturing organizations and coordination of product serialization for distribution.
Implementation of quality assurance programs, continuous improvement initiatives, and supplier performance management systems to ensure manufacturing quality.
Microbiological laboratory services including environmental monitoring, sterility testing, bacterial endotoxin testing, particulate matter testing, and water analysis.
Preparation and maintenance of Drug Master Files and support for regulatory submissions including ANDAs, 505(b)(2) NDAs, and device-related filings.
Expertise Areas
- Generic drug development and regulatory approval (ANDA, 505(b)(2) NDA)
- Formulation development for oral and injectable dosage forms
- Sterile manufacturing and aseptic processing
- Chemical API process development and scale-up
Key Technologies
- Oral solid dosage formulation
- Injectable formulation (ready-to-use solutions and lyophilized)
- Spray/alternate-route delivery systems
- Aseptic filling and sterile processing
News & Updates
Navinta received FDA approval for MARAVIROC on May 13, 2025.
Navinta received FDA approval for MIGLUSTAT on March 14, 2025.
Navinta received FDA approval for SEVELAMER HYDROCHLORIDE on February 3, 2025.
Navinta received FDA approval for SODIUM PHENYL ACETATE and SODIUM BENZOATE on July 14, 2023.
Navinta received FDA approval for CARGLUMIC ACID on June 22, 2022.
Navinta received FDA approval for PENICILLAMINE on October 8, 2021.
Navinta received FDA approval for MARAVIROC on May 13, 2025.
Navinta received FDA approval for MIGLUSTAT on March 14, 2025.
Navinta received FDA approval for SEVELAMER HYDROCHLORIDE on February 3, 2025.
Navinta received FDA approval for SODIUM PHENYL ACETATE and SODIUM BENZOATE on July 14, 2023.
Navinta received FDA approval for CARGLUMIC ACID on June 22, 2022.
Navinta received FDA approval for PENICILLAMINE on October 8, 2021.