What Dexcel Pharma USA does

Dexcel Pharma USA is a privately held U.S. specialty pharmaceutical company headquartered in Parsippany, New Jersey, and operating as a wholly-owned subsidiary of Dexcel Pharma — Israel's largest private pharmaceutical company, founded in 1968 and serving more than 30 markets globally. The company was originally founded around 2010 as Edenbridge Pharmaceuticals, LLC, was acquired by Dexcel Pharma in June 2022, and rebranded as Dexcel Pharma USA in October 2024. It commercializes a diversified portfolio of generic, branded, and specialty prescription pharmaceutical products across multiple therapeutic areas, including cardiology, neurology, gastroenterology, urology, oncology, behavioral health, and rare diseases.

The company's product portfolio spans more than 25 marketed products, anchored by a generics business built through Abbreviated New Drug Application (ANDA) approvals (e.g., Albendazole, Ivermectin, Bisoprolol Fumarate, Pantoprazole Sodium, Prednisolone Sodium Phosphate, Vigabatrin, Nintedanib), a branded franchise including Hemady (dexamethasone) for multiple myeloma and DARTISLA ODT — the first FDA-approved orally disintegrating tablet of glycopyrrolate, manufactured using Catalent's proprietary Zydis freeze-dried delivery technology — plus the recently acquired Zubsolv (buprenorphine/naloxone) for opioid use disorder obtained from Orexo AB in January 2026. Specialty products include Vigabatrin (refractory seizures), Yargesa/miglustat (Gaucher disease), and Nintedanib (Idiopathic Pulmonary Fibrosis). Notable regulatory milestones include the first WHO Prequalification for Ivermectin globally and multiple first-to-file FDA generic approvals.

Dexcel Pharma USA generates revenue through one-time product sales across three categories — generic, branded, and specialty pharmaceuticals — distributed via specialty pharmacy partners (Orsini, Birdi, Gentry Health Services), a digital commercialization/eHub partner (Phil for DARTISLA ODT), traditional wholesale distribution, and retail pharmacy channels. Go-to-market is sales-led with a dedicated sales and marketing team, supplemented by healthcare provider outreach and patient assistance programs. Pricing is not publicly disclosed and is quote-based through a direct sales team. The customer base spans U.S. healthcare providers, pharmacies, and patients across diverse therapeutic segments, with end-demand diffused across the U.S. patient population.

Name

Dexcel Pharma USA

Legal name

Edenbridge Pharmaceuticals, LLC

Website

https://dexcelpharmausa.com

Company type

Private

Founded year

2010

Operating status

Operating

Short description

Dexcel Pharma USA is a privately held U.S. pharmaceutical company that develops, manufactures, and commercializes generic, branded, and specialty prescription products across cardiology, neurology, gastroenterology, oncology, and rare diseases, serving U.S. healthcare providers, pharmacies, and patients through specialty pharmacy and retail distribution channels.

Ownership category

akta.pro rank

Product category

Generic and Specialty Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254), Drugs and Druggists' Sundries Merchant Wholesalers (424210)

SIC

Pharmaceutical Preparations (2834), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)

akta.pro primary industry

Oral Solid Dose (OSD) Generics (HLAIABAD)

akta.pro secondary industries

Specialty Care Pharmaceuticals (HLAIAAAB), Specialty Pharmaceutical Distributors (HLAIAJAB), Specialty Pharma & Biologics Distribution (GDP-compliant) (HLAGAMAD), Specialty Pharmacy & Biologics Distribution (CRAOAHAD)

Keywords

• Generic pharmaceuticals
• Specialty pharmaceuticals
• Rare disease treatments
• Prescription drug distribution
• Branded pharmaceuticals

Headquarters

HQ city

Parsippany

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Generic Pharmaceutical Products: Revenue from development and sale of generic pharmaceutical products including Albendazole, Atropine Sulfate, Bisoprolol Fumarate, Bumetanide, Carbidopa, Colestipol, Diclofenac, Donepezil, Isosorbide Mononitrate, Ivermectin, Loperamide, Methenamine Mandelate, Opium Tincture, Pantoprazole, Prednisolone, Tinidazole, Tofacitinib, and Venlafaxine across multiple therapeutic areas.
2. Branded Pharmaceutical Products: Revenue from branded products including Hemady (dexamethasone) for multiple myeloma and Zubsolv (buprenorphine and naloxone) for opioid use disorder. Zubsolv was acquired from Orexo AB in January 2026.
3. Specialty Pharmaceutical Products: Revenue from specialty products including Vigabatrin (for refractory seizures), Yargesa/miglustat (for Gaucher disease), and Nintedanib (for Idiopathic Pulmonary Fibrosis). These products are distributed through specialty pharmacy partners.

Pricing tiers

Go-to-market motion2 records

Distribution channels5 records

Marketing channels3 records

Core offering

Dexcel Pharma USA develops, registers, and commercializes a portfolio of generic, branded, and specialty prescription pharmaceutical products across multiple therapeutic areas including cardiology, neurology, gastroenterology, urology, oncology, and rare diseases. The company markets over 20 generic products plus branded assets such as Hemady and Zubsolv and specialty products for refractory seizures, Gaucher disease, and idiopathic pulmonary fibrosis. Products are distributed through specialty pharmacy partners, traditional pharmaceutical distribution channels, and a direct sales team across the United States.

Product overview

Dexcel Pharma USA operates a diversified pharmaceutical portfolio consisting of generic, branded, and specialty products across multiple therapeutic areas including cardiology, neurology, gastroenterology, urology, and rare diseases. The generic portfolio includes over 20 products such as Albendazole, Atropine Sulfate, Bisoprolol Fumarate, Bumetanide, Carbidopa, Colestipol, Diclofenac Sodium, Donepezil, Isosorbide Mononitrate, Ivermectin, Loperamide, Methenamine Mandelate, Opium Tincture, Pantoprazole Sodium, Prednisolone Sodium Phosphate, Tinidazole, Tofacitinib, and Venlafaxine. The branded portfolio includes Hemady (dexamethasone) for multiple myeloma treatment and Zubsolv (acquired from Orexo) for opioid use disorder treatment. Specialty products include Vigabatrin for seizures, Yargesa for Gaucher disease, Nintedanib for Idiopathic Pulmonary Fibrosis, and DARTISLA ODT for peptic ulcers. The company distributes through specialty pharmacies (Orsini, Birdi, Gentry Health) and retail channels.

Differentiator

Problem solved

Functional benefit

Products and services

• DARTISLA ODT (glycopyrrolate) Orally Disintegrating Tablets First and only FDA-approved orally disintegrating tablet of glycopyrrolate; 1.7 mg strength indicated to reduce symptoms of peptic ulcer as adjunct to treatment in adults. Manufactured using Catalent's Zydis freeze-dried technology so the tablet disperses almost instantly in the mouth without water. For gastroenterology patients and prescribers.
• Hemady (dexamethasone) Tablets FDA-approved 20 mg dexamethasone corticosteroid tablets indicated in combination with other anti-myeloma products for treatment of adults with multiple myeloma. For oncologists and multiple myeloma patients.
• Zubsolv (buprenorphine and naloxone) Sublingual Tablets Sublingual buprenorphine/naloxone tablets in multiple strengths (0.7mg/0.18mg to 11.4mg/2.9mg) indicated for medication-assisted treatment of opioid use disorder. Acquired by Dexcel Pharma USA from Orexo AB in January 2026. For behavioral health prescribers and patients with opioid use disorder.
• Vigabatrin Tablets, USP Generic version of Sabril (500 mg vigabatrin tablets) indicated as adjunctive therapy for refractory complex partial seizures in patients 2 years and older and as monotherapy for infantile spasms in infants 1 month to 2 years. Distributed through Orsini, Birdi, and Gentry Health Services specialty pharmacies. For neurologists and patients with refractory seizure disorders.
• Yargesa (miglustat) Capsules Generic version of Zavesca (100 mg miglustat capsules) indicated for treatment of adult patients with mild to moderate type 1 Gaucher disease. Distributed through Orsini Specialty Pharmacy. For rare disease specialists and Gaucher disease patients.
• Nintedanib Capsules Generic equivalent of Boehringer Ingelheim's OFEV in 100 mg and 150 mg dosages, indicated for treatment of Idiopathic Pulmonary Fibrosis. Distributed through specialty pharmacy and pharmaceutical distribution channels. For pulmonologists and IPF patients.
• Ivermectin Tablets, USP Generic version of Stromectol (3 mg ivermectin tablets) indicated for treatment of strongyloidiasis and onchocerciasis. First FDA-approved generic version of Stromectol; first ivermectin product worldwide to be added to the WHO Prequalified Medicines List. For infectious disease and parasitology prescribers.
• Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP Generic version of Ziac (bisoprolol fumarate/hydrochlorothiazide combination tablets) in 2.5mg/6.25mg, 5mg/6.25mg, and 10mg/6.25mg strengths, indicated for management of hypertension. For cardiologists and primary care prescribers.
• Diltiazem Hydrochloride Tablets, USP Generic version of Cardizem (diltiazem hydrochloride tablets) in 30 mg, 60 mg, 90 mg, and 120 mg strengths, indicated for cardiovascular conditions. For cardiologists and primary care prescribers.
• Isosorbide Mononitrate Extended-Release Tablets, USP Generic version of Imdur Extended-Release Tablets (isosorbide mononitrate) in 30 mg, 60 mg, and 120 mg strengths, indicated for prevention of angina pectoris due to coronary artery disease. For cardiology prescribers.
• Albendazole Tablets, USP Generic version of Albenza (200 mg albendazole tablets), an anthelmintic indicated for treatment of parasitic infections. For infectious disease prescribers.
• Atropine Sulfate Ophthalmic Solution, 1% Sterile 1% atropine sulfate ophthalmic solution for topical use, available in 2 mL, 5 mL, and 15 mL fills. For ophthalmologists.
• Bumetanide Tablets, USP Authorized generic version of Bumex (bumetanide tablets) in 0.5 mg, 1 mg, and 2 mg strengths, a loop diuretic indicated for treatment of edema associated with congestive heart failure, hepatic and renal disease. Launched in partnership with Validus Pharmaceuticals LLC. For cardiology and primary care prescribers.
• Carbidopa Tablets Generic version of Lodosyn (25 mg carbidopa tablets) indicated for use with carbidopa-levodopa in treatment of Parkinson's Disease symptoms. For neurology prescribers.
• Colestipol Hydrochloride Tablets, USP Generic version of Colestid (1 gm colestipol hydrochloride tablets) for cholesterol management. For cardiology and primary care prescribers.
• Diclofenac Sodium Extended-Release Tablets, USP Generic version of Voltaren-XR (100 mg diclofenac sodium extended-release tablets) for relief of osteoarthritis and rheumatoid arthritis symptoms. For rheumatology and primary care prescribers.
• Donepezil Hydrochloride Tablets Generic version of Aricept (donepezil hydrochloride tablets) available in 30 count and 90 count sizes for cognitive function support. For neurology prescribers treating dementia.
• Loperamide Hydrochloride Capsules, USP Generic version of Imodium (2 mg loperamide hydrochloride capsules) indicated for control and symptomatic relief of acute and chronic diarrhea. For gastroenterology and primary care prescribers.
• Methenamine Mandelate Tablets, USP Urinary antiseptic tablets (methenamine mandelate USP) available in 500 mg and 1,000 mg strengths for urinary tract infection prophylaxis. For urology and primary care prescribers.
• Opium Tincture, USP (Deodorized) Antidiarrheal opium tincture USP (deodorized) available in 118 mL and 473 mL bottles for control of severe diarrhea. For gastroenterology prescribers.
• Pantoprazole Sodium for Delayed-Release Oral Suspension Generic version of Protonix for delayed-release oral suspension (pantoprazole sodium 40 mg packets), indicated for healing of erosive esophagitis, maintenance of healing, and pathological hypersecretory conditions including Zollinger-Ellison Syndrome. For gastroenterology prescribers.
• Prednisolone Sodium Phosphate Oral Solution Generic version of Millipred and Veripred (prednisolone sodium phosphate oral solution) in 10 mg, 15 mg, 20 mg, and 25 mg per 5 mL strengths (grape flavored), corticosteroid for inflammatory and allergic conditions. For pediatric and primary care prescribers.
• Tinidazole Tablets, USP Generic version of Tindamax (tinidazole tablets) in 250 mg and 500 mg strengths, an antiprotozoal and antibacterial agent. For infectious disease and gastroenterology prescribers.
• Tofacitinib Extended-Release Tablets Generic version of Xeljanz (11 mg tofacitinib extended-release tablets) used for treatment of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. For rheumatology and gastroenterology prescribers.
• Venlafaxine Extended-Release Tablets Generic venlafaxine extended-release tablets in 75 mg, 150 mg, and 225 mg strengths, an antidepressant indicated for treatment of major depressive disorder and social anxiety disorder. For psychiatry and primary care prescribers.
• Ethacrynic Acid Tablets, USP First FDA-approved generic version of Edecrin (25 mg ethacrynic acid tablets), a loop diuretic indicated for treatment of edema. For cardiology and primary care prescribers.
• Amantadine Hydrochloride Tablets Generic version of Symmetrel (100 mg amantadine hydrochloride tablets) indicated for prophylaxis and treatment of influenza A virus and treatment of parkinsonism. For neurology and infectious disease prescribers.
• Doxepin Hydrochloride Capsules, USP Generic version of Sinequan (150 mg doxepin hydrochloride capsules), a tricyclic antidepressant. For psychiatry and primary care prescribers.
• Aminocaproic Acid Tablets, USP Generic version of Amicar (500 mg aminocaproic acid tablets) indicated for enhancing hemostasis when fibrinolysis contributes to bleeding. For hematology and surgical prescribers.
• Etodolac Tablets, USP Generic version of Lodine (etodolac tablets) in 400 mg and 500 mg strengths, an NSAID indicated for osteoarthritis, rheumatoid arthritis, and acute pain. For rheumatology and primary care prescribers.

Quantifiable outcome

• Hemady reduces complexity of multiple myeloma treatment by reducing number of dexamethasone tablets in regimen
• +1 more outcomes

Named customers4 records

Segments6 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Eight partnerships are on record, tiered core and minor.

• Orexo ABcoreStrategic or Co-development Partner · 7 January 2026Dexcel Pharma USA completed an Asset Purchase Agreement with Orexo AB to acquire the U.S. rights to Zubsolv (buprenorphine and naloxone) sublingual tablets along with associated commercial infrastructure. This acquisition provides new capabilities to promote branded products and supports strategic growth objectives in the U.S. market.
• DLA Piper LLP (US)minorImplementation/ SI/ Consulting Partner · 7 January 2026Legal advisor to Dexcel Pharma USA in connection with the Zubsolv asset purchase transaction with Orexo AB.
• PhilcoreChannel Partner/ Reseller/ Distributor · 28 February 2022Phil serves as commercialization partner and eHub for DARTISLA ODT, providing patient onboarding, affordable distribution, and retail pharmacy channel access throughout the United States.
• CatalentcoreOEM/ Whitelabel/ Licensing Partner · 17 December 2021Catalent manufactures DARTISLA ODT using their proprietary Zydis orally disintegrating tablet delivery technology, creating a freeze-dried tablet that disperses almost instantly in the mouth without water.
• Orsini Specialty PharmacycoreChannel Partner/ Reseller/ DistributorNationwide, independent specialty pharmacy focused on rare diseases and gene therapies. Preferred distribution partner for Yargesa (miglustat), Vigabatrin, and Nintedanib products.
• BirdiminorChannel Partner/ Reseller/ DistributorSpecialty pharmacy partner for Vigabatrin distribution with patient support services.
• Gentry Health ServicesminorChannel Partner/ Reseller/ DistributorSpecialty pharmacy partner for Vigabatrin distribution with patient support services.
• Validus Pharmaceuticals LLCminorChannel Partner/ Reseller/ DistributorPartnership with Validus to launch an exclusive authorized generic version of Bumex (bumetanide tablets) in 0.5mg, 1mg, and 2mg dosage strengths.

Scale indicators3 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Upsher-Smith Laboratories: U.S. privately held pharmaceutical company with generics and specialty products across neurology, women's health, and dermatology — comparable mid-cap size, portfolio diversity, and channel strategy through specialty pharmacy partnerships.
• ANI Pharmaceuticals: U.S. specialty generics company focused on rare disease, niche generics, and 505(b)(2) products — closely comparable business model centered on specialty distribution partnerships, niche therapeutic areas, and FDA-approved abbreviated applications.
• Lannett Company: U.S. generics and specialty pharmaceutical manufacturer headquartered near Philadelphia, PA, with a comparable portfolio of generic and authorized-generic products across therapeutic areas; leadership overlap (former Lannett executives at Dexcel Pharma USA) reinforces operational comparability.
• Amneal Pharmaceuticals: U.S.-focused specialty and generics pharmaceutical company with a diversified portfolio across therapeutic areas including neurology, endocrinology, and rare diseases — directly comparable tri-pillar model (generic, branded, specialty) and similar go-to-market through specialty pharmacy and retail channels.
• Padagis: U.S. specialty generics company (spun from Perrigo) focused on niche topical, dermatology, and complex generics — comparable product development focus on differentiated formulations and specialty/limited-competition molecules.

Broad incumbents

• Teva Pharmaceutical Industries: World's largest generic drug manufacturer with a substantial U.S. generics and specialty franchise; competes head-to-head with Dexcel on many of the same generic molecules (Bisoprolol, Pantoprazole, Donepezil, Venlafaxine) but at vastly greater scale.
• Sandoz: Novartis's generics and biosimilars division with one of the largest U.S. generic footprints; competes with Dexcel on numerous oral solid dose generics and increasingly on specialty/biosimilars — a much larger incumbent in the same categories.
• Viatris: Global generics and specialty pharmaceutical company (Mylan/Pfizer Upjohn combination) with broad U.S. presence across most of Dexcel's therapeutic categories — significantly larger but overlapping portfolio and channels.
• Endo Pharmaceuticals: Larger U.S. specialty generics and branded pharmaceutical company with overlapping therapeutic areas (pain, neurology, urology) and comparable specialty-pharmacy distribution model — broader portfolio scale but similar go-to-market in adjacent categories.

Emerging players

• Zydus Pharmaceuticals USA: U.S. subsidiary of India's Zydus Lifesciences, focused on generics, specialty, and biosimilars in the U.S. market — comparable international parent backing, ANDA-driven portfolio, and growing specialty footprint.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 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 Dexcel Pharma USA