Jerome Stevens Pharmaceuticals
Family-owned pharmaceutical manufacturer focused on oral solid-dose products. The company states a long-term commitment to product quality and safety, operates manufacturing and technical operations functions, and holds an FDA New Drug Application (NDA) for an FDA-recognized levothyroxine reference product.
Industries
Nr. of Employees
medium (51-250)
Jerome Stevens Pharmaceuticals
Patents
Sustained drug release and improved product stability using non-covalent particle coating methods
US-9526701-B2
View Details
Sustained drug release and improved product stability using non-covalent particle coating methods
US-9526701-B2
View DetailsProducts
Levothyroxine sodium tablets (FDA-recognized reference product)
An FDA-recognized levothyroxine sodium, USP oral tablet product; identified in company materials as the first FDA-approved levothyroxine product for hypothyroidism and established as a reference drug.
Digoxin (digitalis-derived cardiac medication)
Oral digoxin product used to increase cardiac contractility and help control heart rate and rhythm in certain heart conditions.
Levothyroxine sodium tablets (FDA-recognized reference product)
An FDA-recognized levothyroxine sodium, USP oral tablet product; identified in company materials as the first FDA-approved levothyroxine product for hypothyroidism and established as a reference drug.
Digoxin (digitalis-derived cardiac medication)
Oral digoxin product used to increase cardiac contractility and help control heart rate and rhythm in certain heart conditions.
Expertise Areas
- Pharmaceutical manufacturing (oral solid dose/tableting)
- Regulatory compliance and NDA management
- Quality control and analytical testing
- Technical operations and manufacturing modernization
Key Technologies
- Tablet compression (oral solid-dose manufacturing)
- Oral solid-dose formulation
- Analytical chemistry and QC assays
- Regulatory submission workflows (NDA lifecycle)
News & Updates
In 2000 the FDA granted the company a New Drug Application (NDA) for its levothyroxine sodium, USP tablets and established it as the reference drug for hypothyroidism.
In 2000 the FDA granted the company a New Drug Application (NDA) for its levothyroxine sodium, USP tablets and established it as the reference drug for hypothyroidism.