Quagen Pharma

What Quagen Pharma does

Quagen Pharmaceuticals LLC is a privately held, integrated generic pharmaceutical company headquartered in West Caldwell, New Jersey. Founded in May 2016 by entrepreneur Ashish Shah, the company develops, manufactures, and distributes prescription and over-the-counter generic medicines across multiple dosage forms including oral solutions, topical creams/ointments/lotions, solid oral tablets (with extended- and sustained-release capability), suppositories, and transdermal patches. Its commercialized portfolio spans approximately 20 FDA-approved generic drugs across therapeutic categories such as allergy (Cyproheptadine, Cetirizine), psychiatry (Aripiprazole, Methylphenidate CII), respiratory (Albuterol, Promethazine/Codeine), pain management including Schedule II opioids (Oxycodone oral solution), dermatology (Halobetasol, Triamcinolone, Clobetasol, Fluocinolone), endocrinology (Propylthiouracil), and oncology-adjacent therapy (Exemestane, Imatinib Mesylate).

The company operates from four FDA- and DEA-approved cGMP facilities in West Caldwell, NJ, totaling over 170,000 square feet. The 11 Patton Drive site (55,000 sq ft) houses formulation, analytical R&D, microbiology, and quality control; 34 Fairfield Place (65,000 sq ft) is dedicated to topical creams, ointments, liquids, and packaging with ISO Class 8 clean rooms and up to 5,000L vessel capacity; 35 Fairfield Place (51,000 sq ft) handles solids manufacturing including extended/sustained-release solids and transdermal patch capabilities; and 37 Fairfield Place (27,000 sq ft) handles distribution of prescription and OTC products. Quagen holds DEA Schedule I through V registrations for both analytical and manufacturing operations — a relatively rare authorization that materially expands its addressable product set into controlled substances.

Quagen serves US healthcare providers and patients through direct distribution channels, using a horizontal segmentation approach across dosage forms and therapeutic categories. Pricing and revenue are not publicly disclosed. Key milestones include ANDA approvals for Imatinib Mesylate Tablets (developed in partnership with Stason Pharmaceuticals, announced February 2019), Exemestane (February 2019), additional ANDAs (September 2019 and March 2021), and a Tetracycline launch (February 2019). In June 2026, the FTC required Aurobindo Pharma to divest four generic products to Quagen as a condition of approving Aurobindo's $250 million acquisition of Lannett Company, adding immunosuppressant, cholesterol management, dry mouth, and GI assets to the portfolio.

Name

Quagen Pharma

Legal name

Quagen Pharmaceuticals LLC

Website

https://quagenpharma.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

51–100 employees

Short description

Quagen Pharmaceuticals LLC is a privately held, integrated generic pharmaceutical manufacturer based in West Caldwell, NJ, producing FDA-approved prescription and OTC medicines across liquids, semisolids, solids, suppositories, and transdermal patches for US healthcare providers and patients.

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

Generic ANDA/Regulatory Affairs & Submissions (HLAIABAJ)

akta.pro secondary industries

Controlled Substances / DEA-Scheduled API Manufacturing (HLAGAHAD), Generic Hospital & Institutional Products (HLAIABAL)

Keywords

• Generic pharmaceutical manufacturing
• Oral solid dosage forms
• Topical pharmaceutical formulations
• Controlled substance manufacturing
• ANDA drug development

Headquarters

HQ city

West Caldwell

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Distribution channels1 record

Core offering

Quagen Pharma develops, manufactures, and distributes a portfolio of FDA-approved generic prescription and OTC medicines across multiple dosage forms, including oral liquids, oral solids, semisolids, suppositories, and transdermal patches. Operations are conducted at FDA- and DEA-approved cGMP facilities in West Caldwell, New Jersey, with DEA Schedule I–V authorization that enables manufacture of controlled substances. The company also packages and ships finished dosage products from an integrated warehouse/distribution facility on the same campus.

Product overview

Quagen Pharma is an integrated generic pharmaceutical company developing, manufacturing, and distributing high-quality prescription and OTC medications across multiple dosage forms including liquids, semisolids, solids, suppositories, and transdermal patches. The company operates FDA and DEA-approved manufacturing facilities in West Caldwell, New Jersey, totaling over 170,000 square feet. Their product portfolio includes oral solutions (Cyproheptadine, Aripiprazole, Cetirizine, Albuterol, Methylphenidate, Promethazine & Codeine, Promethazine, Guaifenesin & Codeine), topical formulations (Halobetasol, Triamcinolone, Fluocinolone oils, Clobetasol, Lidocaine), solid oral tablets (Cyproheptadine, Propylthiouracil), controlled substances (Oxycodone, Methylphenidate, Codeine combinations), and suppositories (Hydrocortisone). The company also acquired four generic drug products from Aurobindo Pharma as part of an FTC consent order related to the Lannett Company acquisition.

Differentiator

Problem solved

Functional benefit

Products and services

• Cyproheptadine Hydrochloride Oral Solution, USP Oral solution formulation of an antihistamine used for allergic reactions, supplied to wholesalers, pharmacies, and healthcare providers.
• Aripiprazole Oral Solution 1 mg/mL Antipsychotic oral solution for treatment of schizophrenia and related conditions, supplied to wholesalers and healthcare providers.
• Cetirizine Hydrochloride Oral Solution, USP Second-generation antihistamine oral solution for allergy relief, supplied to wholesalers, pharmacies, and healthcare providers.
• Albuterol Sulfate Syrup Bronchodilator syrup for treatment of asthma and respiratory conditions, supplied to wholesalers and healthcare providers.
• Methylphenidate Hydrochloride Oral Solution, CII CNS stimulant oral solution for ADHD treatment, classified as Schedule II controlled substance, supplied to DEA-registered wholesalers and pharmacies.
• Promethazine & Codeine Phosphate Oral Solution CV Combination antihistamine and cough suppressant oral solution, classified as Schedule V controlled substance, supplied to DEA-registered wholesalers and pharmacies.
• Halobetasol Propionate Ointment, 0.05% Topical corticosteroid ointment for inflammatory skin conditions, supplied to wholesalers and healthcare providers.
• Triamcinolone Acetonide Lotion, USP Topical corticosteroid lotion for skin inflammation and itching, supplied to wholesalers, pharmacies, and healthcare providers.
• Cyproheptadine Hydrochloride Tablets, USP Antihistamine tablets for allergic reactions, supplied to wholesalers, pharmacies, and healthcare providers.
• Propylthiouracil Tablets, USP 50 mg Antithyroid medication for hyperthyroidism treatment, supplied to wholesalers and healthcare providers.
• Lidocaine Ointment USP, 5% Topical anesthetic ointment for pain relief and numbing, supplied to wholesalers and healthcare providers.
• Oxycodone Hydrochloride Oral Solution, USP (CII) Opioid analgesic oral solution for severe pain management, classified as Schedule II controlled substance, supplied to DEA-registered wholesalers, pharmacies, and hospitals.
• Promethazine Hydrochloride Oral Solution Antihistamine and antiemetic oral solution, supplied to wholesalers, pharmacies, and healthcare providers.
• Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) Topical corticosteroid body oil for skin conditions affecting the body, supplied to wholesalers and healthcare providers.
• Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) Topical corticosteroid oil for scalp skin conditions, supplied to wholesalers and healthcare providers.
• Fluocinolone Acetonide Oil, 0.01% (Ear Drops) Topical corticosteroid ear drops for ear inflammation, supplied to wholesalers, pharmacies, and healthcare providers.
• Guaifenesin and Codeine Phosphate Oral Solution C-V Expectorant and cough suppressant combination oral solution, classified as Schedule V controlled substance, supplied to DEA-registered wholesalers and pharmacies.
• Hydrocortisone Acetonide Suppositories 25 mg Rectal suppository formulation of corticosteroid for inflammatory conditions, supplied to wholesalers, pharmacies, and healthcare providers.
• Clobetasol Propionate Topical Solution USP, 0.05% High-potency topical corticosteroid solution for severe skin conditions, supplied to wholesalers and healthcare providers.
• Imatinib Mesylate Tablets Generic for Gleevec (Novartis); tyrosine kinase inhibitor oral tablets for chronic myeloid leukemia and related cancers. Developed in collaboration with Stason Pharmaceuticals, commercially manufactured by Stason in 100mg and 400mg strengths under a development collaboration with Quagen. Supplied to wholesalers and healthcare providers.
• Exemestane Tablets Generic aromatase inhibitor oral tablets for breast cancer treatment; FDA-approved via ANDA process in February 2019. Supplied to wholesalers, specialty pharmacies, and oncology healthcare providers.
• Aurobindo/Lannett Divestiture Generic Products (Mycophenolate Mofetil Oral Suspension, Niacin Extended Release Tablets, Pilocarpine Tablets, Rabeprazole Sodium Delayed Release Tablets) Four generic pharmaceutical products acquired in June 2026 from Aurobindo Pharma pursuant to FTC consent order: mycophenolate mofetil oral suspension (immunosuppressant), niacin extended release tablets (cholesterol management), pilocarpine tablets (dry mouth treatment for radiation therapy patients), and rabeprazole sodium delayed release tablets (stomach acid reduction). Supplied to wholesalers, specialty distributors, and healthcare providers.

Segments1 record

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Two partnerships are on record, tiered major and core.

• Aurobindo PharmamajorStrategic or Co-development Partner · 22 June 2026As part of FTC approval for Aurobindo's $250 million acquisition of Lannett Company, Quagen Pharma acquired four generic pharmaceutical products (mycophenolate mofetil oral suspension, niacin extended release tablets, pilocarpine tablets, and rabeprazole sodium delayed release tablets) from Aurobindo. This was a required divestiture to prevent anticompetitive market conditions.
• Stason Pharmaceuticals Inc.coreStrategic or Co-development PartnerQuagen's Imatinib Mesylate Tablets (generic for Gleevec by Novartis) was developed in collaboration with Stason Pharmaceuticals Inc. Stason commercially manufactures the product in 100mg and 400mg strengths.

Scale indicators4 records

Recent moves6 records

Expansion highlights4 records

Broad incumbents

• Glenmark Pharmaceuticals: India-headquartered global generic and specialty pharmaceutical company with significant US presence. Comparable as a foreign-headquartered generic manufacturer supplying the US market across multiple dosage forms and therapeutic categories.
• Zydus Pharmaceuticals (USA): US arm of India-based Zydus Cadila, manufacturing and distributing generic pharmaceuticals across dosage forms in the US market. Comparable as an Indian-origin generic player with US FDA-approved manufacturing, overlapping with Quagen on solid oral generics and topical categories.
• Aurobindo Pharma: India-headquartered global generic manufacturer with major US operations producing across solids, injectables, and controlled substances. Comparable to Quagen through the FTC-mandated product divestiture and overlapping US generic portfolio, but significantly larger and globally diversified.
• Alkem Laboratories: India-based generic pharmaceutical manufacturer with US operations and ANDA pipeline. Comparable as an India-headquartered generic player with US FDA-approved manufacturing competing across many of the same therapeutic categories as Quagen.
• Endo International: US-based specialty and generic pharmaceutical company with branded and generic segments including sterile injectables and specialty generics. Comparable to Quagen through US generic manufacturing footprint and overlapping specialties in controlled and specialty dosage forms.
• Teva Pharmaceutical Industries: World's largest generic pharmaceutical manufacturer with extensive US operations and broad portfolio across nearly every generic therapeutic category. Comparable to Quagen through overlapping generic product portfolio, though at vastly larger scale and with global manufacturing and distribution.

Direct peers

• Lannett Company: US-based generic pharmaceutical manufacturer focused on oral solids, topicals, and specialty generics. Directly comparable as a US private/now-acquired mid-market generic manufacturer with overlapping therapeutic categories and customer channels (just acquired by Aurobindo with FTC-required products divested to Quagen).
• Amneal Pharmaceuticals: US-headquartered generic and specialty pharmaceutical manufacturer producing across dosage forms including solids, injectables, and transdermal patches. Comparable to Quagen as a US-focused mid-size generic manufacturer with multi-dosage-form capabilities and overlapping therapeutic categories.
• Apotex: Privately held Canadian generic pharmaceutical manufacturer with US operations producing generics across multiple dosage forms. Directly comparable to Quagen as a privately controlled generic manufacturer with vertically integrated development and manufacturing capabilities and similar product format breadth.
• Stason Pharmaceuticals: US-based pharmaceutical company focused on developing and manufacturing generic and specialty pharmaceuticals including oncology products. Directly comparable to Quagen as a generic pharma partner of similar scale with which Quagen co-developed Imatinib Mesylate Tablets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/quagenpharmaceuticals

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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 Quagen Pharma