What Nivagen Pharmaceuticals does

Nivagen Pharmaceuticals is a specialty pharmaceutical company founded in 2009 and headquartered in Sacramento, California. The company develops, manufactures, and commercializes generic pharmaceuticals with primary focus on sterile injectable products and 505(b)(2) development pathways, supplemented by oral solid dose capabilities. It operates three facilities across California: a 100,000 sq ft c-GMP compliant sterile injectable plant in Sacramento, an OSD facility in Pittsburg, and an R&D center in Davis.

The commercial portfolio comprises 32+ approved ANDAs marketed in the United States, supported by 22+ molecules in development and 20+ ready-to-use (RTU) injectable products in the pipeline. Nivagen holds 13 granted patents and has launched 11+ new products over the prior two-year window. The company has formed a joint venture with an AI formulation company to advance long-acting injectables, including GLP-1 receptor agonists, signaling an intent to participate in the high-growth metabolic therapy segment.

Nivagen generates revenue by selling generic sterile injectable and OSD products through 160 national distribution points to hospital systems, retail pharmacy chains, and institutional buyers under typical generic pharma pricing dynamics. The company has 11-50 employees and has raised approximately $31M across funding rounds in 2017, 2020, and 2023. In January 2026, Nivagen was acquired by PAI Pharma, an Olympus Partners portfolio company, marking its transition to private equity ownership.

Name

Nivagen Pharmaceuticals

Legal name

Nivagen Pharmaceuticals, Inc.

Website

https://nivagen.com

Company type

Private

Founded year

2009

Operating status

Acquired

Headcount range

11–50 employees

Short description

Nivagen Pharmaceuticals is a Sacramento-based specialty pharmaceutical company that develops, manufactures, and commercializes generic sterile injectable and oral solid dose products, serving US hospital, pharmacy, and institutional customers through 32+ approved ANDAs across three California facilities.

Ownership category

akta.pro rank

Product category

Generic Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Contract Development & Manufacturing for Generics (CDMO/CMO) (HLAIABAI)

akta.pro secondary industries

Sterile Injectable Generics (HLAIABAC), Generic Finished Dosage Form (FDF) Manufacturing (HLAIABAH), Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH), Small-Molecule Drug Product (Solid/Oral/Parenteral) CDMO (HLAGABAB)

Keywords

• Generic pharmaceuticals
• Sterile injectables
• CDMO services
• 505(b)(2) development
• Pharmaceutical manufacturing

Headquarters

HQ city

Sacramento

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Operations, Personnel, Marketing or Sales, Supply Chain, Infrastructure, Others

Revenue model

1. Generic Prescription Drugs: Development, manufacturing, and sales of generic prescription drugs and over-the-counter products for the North American market
2. Sterile Injectables: Manufacturing and marketing of sterile injectables including IV bags, vials, PFS and cartridges
3. 505(b)(2) Products: Development and commercialization of 505(b)(2) new drug applications for complex branded and generic products
4. CDMO Services: Contract Development and Manufacturing Organization services offering end-to-end development and manufacturing solutions including drug discovery, clinical trial supplies, and commercial supply
5. 503B Compounding Pharmacy: Compounding pharmacy services for healthcare providers and patients
6. Out-Licensing: Licensing of generic and value-added medicines to partners for product range expansion and market entry

Go-to-market motion3 records

Distribution channels4 records

Marketing channels4 records

Core offering

Nivagen Pharmaceuticals is a specialty pharmaceutical company that develops, manufactures, and markets generic prescription drugs, over-the-counter products, and sterile injectable pharmaceutical products (IV bags, vials, prefilled syringes, cartridges, and ophthalmics). The company also offers CDMO services spanning drug discovery, clinical trial supplies, and commercial manufacturing, as well as 503B compounding services and out-licensing of generic and value-added medicines. Operations are anchored by a 100,000 sq ft c-GMP sterile injectables facility in Sacramento, CA and an oral solid dosage facility in Pittsburg, CA.

Product overview

Nivagen Pharmaceuticals is a specialty pharmaceutical company offering a diversified portfolio of generic prescription drugs, sterile injectable products (IV bags, vials, prefilled syringes, cartridges, and ophthalmics), and 505(b)(2) complex drug formulations through CDMO services. The company operates a 100,000 sq ft c-GMP sterile manufacturing facility in Sacramento, CA and an oral solid dosage facility in Pittsburg, CA with 200 million tablet capacity. CDMO services span the full drug lifecycle from development through commercialization, including formulation development, analytical services, controlled drug handling, drug stability testing, visual inspection, supply chain management, and pharmaceutical packaging. The 505(b)(2) pipeline includes 13 products (NP-001 through NP-013), complementing the core generic portfolio of marketed products like Niva Thyroid, Carbamazepine, Celecoxib, and Metformin ER.

Differentiator

Problem solved

Functional benefit

Products and services

• Niva Thyroid (Thyroid Tablets, USP) Prescription thyroid medication available in 15mg, 30mg, 60mg, 90mg, and 120mg dosages for thyroid hormone replacement therapy, sold under the Nivagen label.
• Carbamazepine 200mg Tablets Anticonvulsant generic medication available in bottles of 100 and 1000 tablets for the treatment of epilepsy and trigeminal neuralgia.
• Celecoxib Capsules COX-2 selective NSAID available in 50mg, 100mg, 200mg, and 400mg capsule formulations for pain and inflammation management.
• Chlorthalidone Tablets Thiazide-like diuretic available in 25mg and 50mg tablets for hypertension treatment.
• Diclofenac Sodium and Misoprostol Tablets Combination NSAID with gastrointestinal protective agent available in 50mg and 75mg formulations for arthritis and pain management with GI protection.
• Levetiracetam ER Tablets Extended-release antiepileptic medication available in 500mg and 750mg strengths in bottles of 60 tablets for seizure management.
• Metformin ER 500mg Extended-release biguanide antidiabetic medication for type 2 diabetes management, available in bottles of 100 and 500 tablets.
• Nateglinide Tablets Meglitinide antidiabetic agent available in 60mg and 120mg strengths for postprandial glucose control in type 2 diabetes patients.
• Sodium Bicarbonate Injection USP 8.4% FDA-approved generic sterile injectable for acidosis treatment and urine alkalinization, addressing critical drug shortages in the U.S. market.
• CDMO Services Full-scale Contract Development and Manufacturing Organization offering end-to-end development and manufacturing solutions across the drug lifecycle, including drug discovery, clinical trial supplies, and commercial supply of sterile injectables, targeting pharmaceutical companies globally.
• Sterile Injectables Manufacturing c-GMP sterile manufacturing service spanning 100,000 sq ft in Sacramento, CA producing IV bags (aseptic and terminally sterilized), vials, prefilled syringes, cartridges, and ophthalmics for pharmaceutical companies.
• Oral Solid Dosage Manufacturing Contract manufacturing service with capacity of up to 200 million tablets per year including dispensing, granulation, drying, milling, blending, compression, and packing under ISO 8 conditions at the Pittsburg, CA facility.
• Controlled Drugs Handling DEA-registered secure handling service for Schedule II and Schedule III controlled substances with strict storage protocols, tracking documentation, and regulatory compliance.
• Drug Stability Testing Release testing and ICH stability testing services ensuring quality and safety of final pharmaceutical products, including accelerated, long-term, and photostability studies.
• Visual Inspection Visual inspection services for sterile products from cartridges to vials, ensuring compliance with stringent regulatory standards for parenteral products.
• Supply Chain Services End-to-end supply chain planning including supplier evaluation, contract manufacturing organization coordination, commercial production planning, and inventory management, maintaining over 100 SKUs in stock.
• Pharmaceutical Packaging Innovative, secure, and compliant packaging solutions tailored to unique product ranges, compliant with international pharmaceutical regulations.
• 503B Compounding Pharmacy 503B outsourcing compounding pharmacy service providing high-quality compounded medications for healthcare providers and patients, addressing drug shortages and customized medication needs in the institutional channel.
• 505(b)(2) Pipeline (NP-001 to NP-013) Portfolio of 13 complex drug development programs (NP-001 through NP-013) utilizing the 505(b)(2) regulatory pathway for streamlined NDA approval, covering various stages from development through submission and approval.
• Out-Licensing Licensing of Nivagen's diverse portfolio of generic and value-added medicines to partners worldwide for product range expansion and market entry.

Quantifiable outcome

• Zero FDA inspection observations in March 2024 PADE audit
• +4 more outcomes

Named customers6 records

Segments5 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core and strategic.

• PAI PharmacoreStrategic or Co-development Partner · 6 January 2026PAI Pharma, a portfolio company of Olympus Partners and leading U.S. developer of oral liquid medicines, acquired Nivagen Pharmaceuticals in January 2026. The acquisition provides PAI with Nivagen's state-of-the-art Sacramento facility, over 20 ready-to-use sterile injectable products in development, and a combined pipeline of approximately 30 sterile products. Transaction strengthens domestic pharmaceutical manufacturing capacity.
• AI Formulation CompanystrategicStrategic or Co-development Partner · 1 January 2024Major joint venture agreement with AI formulation company for long-acting injectable including GLP1 products. This partnership focuses on innovative drug delivery systems development.

Scale indicators14 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Amphastar Pharmaceuticals: Amphastar is a US-based specialty pharmaceutical company focused on injectable and intranasal generic products with in-house manufacturing — directly comparable to Nivagen's sterile injectable and 505(b)(2) focus and similar size profile.
• Hikma Pharmaceuticals: Hikma is a global generic pharmaceutical manufacturer with a large US sterile injectable business (Hikma Injectables) and broad portfolio across generics and specialty — overlapping directly with Nivagen's sterile injectables, generics and CDMO offerings.
• Lannett Company: Lannett is a US generic pharmaceutical manufacturer with a portfolio spanning oral solids, injectables and specialty products — closely comparable to Nivagen in scale, US market focus and product mix.
• Amneal Pharmaceuticals: Amneal is a US-based developer and manufacturer of generic and specialty pharmaceuticals, including injectables — directly comparable to Nivagen's generic + 505(b)(2) + sterile injectable model (Nivagen's VP R&D, Dr. Nirav Patel, previously worked at Amneal).
• Apotex Inc. Apotex is one of Canada's largest generic pharmaceutical manufacturers producing generics, injectables and biosimilars — overlapping with Nivagen across generics, sterile injectables and CDMO/in-licensing activities.
• PCI Pharma Services: PCI Pharma Services is a global contract development and manufacturing organization (CDMO) with extensive sterile injectable capabilities — a direct peer to Nivagen's CDMO services offering across formulation, manufacturing and packaging.
• Piramal Pharma Solutions: Piramal Pharma Solutions is a global CDMO offering sterile injectable manufacturing, including injectables and complex generics — closely comparable to Nivagen's CDMO and sterile injectable manufacturing business (Nivagen's VP Projects, Venkatesh Muttepwar, previously worked at Piramal).

Broad incumbents

• Endo International: Endo (through its Par Sterile Products and generics businesses) is a long-established US manufacturer of sterile injectables and generic pharmaceuticals — a broad incumbent in Nivagen's core sterile injectable and generic categories.
• Fresenius Kabi: Fresenius Kabi is a global leader in sterile injectable pharmaceuticals, IV generics and infusion solutions, and a major US supplier to hospitals — competing broadly with Nivagen across hospital sterile injectables and IV bags.
• Aurobindo Pharma: Aurobindo is a global generic and sterile injectable manufacturer with significant US market presence — overlapping broadly with Nivagen across generic oral solids, injectables and CDMO supply.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks1 record

Key highlights7 records

Customer concentration

• Facebookfacebook.com/1385327518432402
• LinkedInlinkedin.com/company/nivagen-pharmaceuticals

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds3 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Nivagen Pharmaceuticals