Aurobindo Pharma USA, Inc.
Vertically integrated generic pharmaceutical company operating API production, formulation development, pilot-scale R&D, commercial manufacturing, automated packaging, warehousing and U.S. distribution. Maintains R&D and pilot-plant capacity for a range of complex dosage forms (oral, injectable, inhalation, topical, transdermal), an online product catalog with prescribing information, and regulatory teams supporting generic product approvals for the U.S. market.
Industries
Nr. of Employees
Very Large (1000+)
Aurobindo Pharma USA, Inc.
Products
U.S. generic pharmaceutical portfolio (online catalog)
Online catalog of generic medicines across oral solids, injectables, inhalation, topical and other categories with product identifiers and links to external prescribing information; catalog contains 1,015 listed product entries.
Active Pharmaceutical Ingredients (APIs) portfolio
Provision of a wide range of APIs supporting internal manufacturing and external partners across multiple therapeutic categories.
R&D and pilot-plant services (Durham, NC)
40,000 sq. ft. R&D and pilot-plant facility with formulation teams and analytical labs supporting specialty product development and pilot commercialization.
U.S. generic pharmaceutical portfolio (online catalog)
Online catalog of generic medicines across oral solids, injectables, inhalation, topical and other categories with product identifiers and links to external prescribing information; catalog contains 1,015 listed product entries.
Active Pharmaceutical Ingredients (APIs) portfolio
Provision of a wide range of APIs supporting internal manufacturing and external partners across multiple therapeutic categories.
R&D and pilot-plant services (Durham, NC)
40,000 sq. ft. R&D and pilot-plant facility with formulation teams and analytical labs supporting specialty product development and pilot commercialization.
Services
Development services for oral controlled-release systems, injectables (including depot and polymer formulations), inhalation (pMDI), topical and transdermal products using on-site R&D and pilot facilities.
cGMP commercial manufacturing services with automated packaging and in-line inspection for multiple dosage forms and packaging formats.
Large-scale warehousing and distribution services with pallet capacity and automated order fulfillment, plus management of an online commercial product catalog.
Regulatory support for preparation and management of ANDA filings and related documentation to obtain FDA approvals for generic products.
Online searchable catalog with product identifiers, dosage forms and links to prescribing information and medication guides.
Development services for oral controlled-release systems, injectables (including depot and polymer formulations), inhalation (pMDI), topical and transdermal products using on-site R&D and pilot facilities.
cGMP commercial manufacturing services with automated packaging and in-line inspection for multiple dosage forms and packaging formats.
Large-scale warehousing and distribution services with pallet capacity and automated order fulfillment, plus management of an online commercial product catalog.
Regulatory support for preparation and management of ANDA filings and related documentation to obtain FDA approvals for generic products.
Online searchable catalog with product identifiers, dosage forms and links to prescribing information and medication guides.
Expertise Areas
- Generic pharmaceutical manufacturing
- Complex dosage-form formulation (oral, injectable, inhalation, topical, transdermal)
- API synthesis and integrated API supply chain
- Biologics and biosimilars development
Key Technologies
- Hot melt extrusion (HME)
- Osmotically controlled-release (OROS) systems
- Pressurized metered-dose inhaler formulation and filling
- Transdermal matrix patch technology
News & Updates
Announcement of FDA final approval for an Abbreviated New Drug Application for potassium chloride oral solution (two strengths) as generic equivalents.
Announcement of FDA final approval for an Abbreviated New Drug Application for fosfomycin tromethamine granules (single-dose sachet) as a generic equivalent.
Announcement of FDA final approval for an ANDA for linagliptin tablets 5 mg (generic equivalent).
Construction start for a new 170,000 sq. ft. building at the East Windsor campus intended as a manufacturing facility to join existing facilities.
Received the Company of the Year, Asia-Pacific Award at the Global Generics & Biosimilars Awards (Generics Bulletin) in 2017.
Recognition by East Windsor Township for community enhancement activities (award announced in 2018).
Announcement of FDA final approval for an Abbreviated New Drug Application for potassium chloride oral solution (two strengths) as generic equivalents.
Announcement of FDA final approval for an Abbreviated New Drug Application for fosfomycin tromethamine granules (single-dose sachet) as a generic equivalent.
Announcement of FDA final approval for an ANDA for linagliptin tablets 5 mg (generic equivalent).
Construction start for a new 170,000 sq. ft. building at the East Windsor campus intended as a manufacturing facility to join existing facilities.
Received the Company of the Year, Asia-Pacific Award at the Global Generics & Biosimilars Awards (Generics Bulletin) in 2017.
Recognition by East Windsor Township for community enhancement activities (award announced in 2018).