Praxgen
Specialty pharmaceutical company focused on development, manufacturing and commercialization of generic prescription medicines. Operates R&D facilities in New Jersey and uses partnerships and contract manufacturers across North America and Asia. Portfolio work includes complex and difficult-to-manufacture dosage forms and multiple US regulatory filings and approvals (ANDA). The company pursues licensing, joint development, and distribution partnerships.
Industries
Nr. of Employees
medium (51-250)
Products
Generic pharmaceutical products (multiple dosage forms)
Approved, marketed or pipeline generic products across tablets/capsules, injectables, ophthalmics, topicals, oral solutions and patches.
Fosaprepitant for Injection 150mg/vial
An approved ANDA drug product used for treatment of cyclic vomiting syndrome and late-stage, chemotherapy-induced vomiting.
Generic Medrol (Methylprednisolone) Tablets 4 mg
A generic version of Medrol (Methylprednisolone) in 4 mg tablets serving the retail pharmaceutical market.
Generic pharmaceutical products (multiple dosage forms)
Approved, marketed or pipeline generic products across tablets/capsules, injectables, ophthalmics, topicals, oral solutions and patches.
Fosaprepitant for Injection 150mg/vial
An approved ANDA drug product used for treatment of cyclic vomiting syndrome and late-stage, chemotherapy-induced vomiting.
Generic Medrol (Methylprednisolone) Tablets 4 mg
A generic version of Medrol (Methylprednisolone) in 4 mg tablets serving the retail pharmaceutical market.
Services
Evaluation and acquisition/licensing of marketed or approved pharmaceutical products and assets for US commercialization.
Co-development of drug products across ANDA, 505(b)(2) and NDA pathways with partners for US and international markets.
Management of manufacturing through third-party partners for sterile injectables and other dosage forms, including manufacturing agreements.
Evaluation and acquisition/licensing of marketed or approved pharmaceutical products and assets for US commercialization.
Co-development of drug products across ANDA, 505(b)(2) and NDA pathways with partners for US and international markets.
Management of manufacturing through third-party partners for sterile injectables and other dosage forms, including manufacturing agreements.
Expertise Areas
- Generic drug development
- Sterile injectable development and manufacture
- Ophthalmic and topical product development
- Oral solid and liquid dosage formulation
Key Technologies
- Sterile injectable manufacturing
- Ophthalmic formulation
- Topical formulation
- Oral solid dosage formulation
News & Updates
Announcement of company name change from prior name to current name to reflect corporate positioning and continuity of product development activities.
Company has received multiple ANDA approvals from the US FDA for a range of generic products, including sterile injectables and oral dosage forms.
Commercial launches and distribution agreements announced for several generic products in the US market via partner arrangements.
Entered into a manufacturing agreement with a third-party aseptic/sterile manufacturer to produce generic injectable products.
Announcement of company name change from prior name to current name to reflect corporate positioning and continuity of product development activities.
Company has received multiple ANDA approvals from the US FDA for a range of generic products, including sterile injectables and oral dosage forms.
Commercial launches and distribution agreements announced for several generic products in the US market via partner arrangements.
Entered into a manufacturing agreement with a third-party aseptic/sterile manufacturer to produce generic injectable products.