Upsher Smith Laboratories

What Upsher Smith Laboratories does

Upsher-Smith Laboratories, LLC is a U.S. pharmaceutical manufacturer founded in 1919 and headquartered in Maple Grove, Minnesota. The company produces and markets both brand-name specialty pharmaceuticals and a broad portfolio of generic medications across multiple dosage forms — tablets, capsules, oral suspensions, topical gels, ophthalmic emulsions, and otic suspensions — spanning cardiovascular, neurology, CNS, ophthalmology, otic, rare-disease (Duchenne muscular dystrophy, infantile spasms, tuberous sclerosis complex), and endocrinology indications. Branded specialty assets include VIGAFYDE (vigabatrin) Oral Solution, VIGADRONE, KYMBEE (deflazacort), TORPENZ (everolimus), QudexY XR, Vogelxo, and Forfivo XL, while the generic catalog exceeds 60 SKUs covering products such as KLOR-CON, JANTOVEN, diltiazem, nifedipine, memantine, cyclosporine ophthalmic emulsion, and ciprofloxacin/dexamethasone otic suspension. Manufacturing is consolidated at Plant C, one of the largest and newest U.S. generics facilities, producing 1.9 billion doses annually with 450+ employees.

The company sells primarily through U.S. pharmaceutical wholesale distribution — McKesson, AmerisourceBergen, and Cardinal Health — reaching retail pharmacies, hospital systems, and specialty pharmacies, with selective direct phone ordering. Revenue is generated through standard prescription product sales (one-time transactions per fill) supplemented by contract development and manufacturing (CDMO) services accessed through parent Bora Pharmaceuticals. Specialty products such as KYMBEE are supported by a dedicated Promise of Support patient services program. Pricing is quote-based and not publicly disclosed. Since April 2024, Upsher-Smith has operated as a wholly-owned subsidiary of Taiwan-based Bora Pharmaceuticals, integrating TWi Pharmaceuticals (July 2024 merger) and Pyros Pharmaceuticals (October 2024 acquisition) into its portfolio.

Name

Upsher Smith Laboratories

Legal name

Upsher-Smith Laboratories, LLC

Website

https://upsher-smith.com

Company type

Private

Founded year

1919

Operating status

Operating

Headcount range

251–500 employees

Short description

Upsher-Smith Laboratories is a 105-year-old U.S. pharmaceutical manufacturer based in Maple Grove, Minnesota, producing generic and branded specialty medications across multiple dosage forms for U.S. retail, hospital, and specialty pharmacy channels, operating as a subsidiary of Bora Pharmaceuticals.

Ownership category

akta.pro rank

Product category

Generic and Specialty Pharmaceuticals

NAICS

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

Drug Substance–Drug Product Integrated CDMO (HLAGABAG), Neurology & CNS Specialty Pharmaceuticals (HLAIACAC), Oncology & Hematology Pharmaceuticals (HLAIAAAC)

Keywords

• Generic pharmaceuticals
• Branded specialty medications
• Pharmaceutical manufacturing
• Rare disease treatments
• Extended-release formulations

Headquarters

HQ city

Maple Grove

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Generic Pharmaceuticals: Sale of FDA-approved generic pharmaceutical products including cyclosporine ophthalmic emulsion, ciprofloxacin/dexamethasone otic suspension, and other generic medications across therapeutic areas
2. Branded Specialty Pharmaceuticals: Sale of branded specialty medications including VIGAFYDE, VIGADRONE, KYMBEE, TORPENZ, and other brand products for complex and rare conditions
3. Contract Development and Manufacturing (CDMO): Manufacturing capabilities leveraged through parent company Bora Pharmaceuticals for CDMO services, including state-of-the-art facility in Maple Grove, Minnesota

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels5 records

Core offering

Upsher-Smith Laboratories manufactures and markets a broad portfolio of branded specialty and generic pharmaceutical products across multiple therapeutic areas, including neurology (vigabatrin, topiramate), cardiology (potassium chloride, warfarin, amiodarone), ophthalmology (cyclosporine emulsion, difluprednate), and rare diseases such as Duchenne muscular dystrophy (deflazacort) and tuberous sclerosis complex (everolimus). The company operates a state-of-the-art U.S. manufacturing facility (Plant C) in Maple Grove, Minnesota, and leverages its parent Bora Pharmaceuticals' CDMO capabilities for contract manufacturing services.

Product overview

Upsher-Smith Laboratories is a U.S. pharmaceutical company that manufactures and markets brand and generic pharmaceutical products across multiple therapeutic areas. The company's portfolio includes a diverse array of medications organized into two main categories: brand specialty products and generic pharmaceuticals. Brand specialty products include VIGAFYDE (vigabatrin) Oral Solution and VIGADRONE (vigabatrin) for infantile spasms, KYMBEE (deflazacort) Tablets and Oral Suspension for Duchenne muscular dystrophy, TORPENZ (everolimus) for tuberous sclerosis complex, QUDEXY XR (topiramate) for migraine prevention, VOGELXO (testosterone) Gel for hormone replacement, and VANDAZOLE (metronidazole) for bacterial vaginosis. The generic portfolio spans cardiovascular medications (KLOR-CON potassium chloride, diltiazem, nifedipine, atenolol, lisinopril, warfarin/JANTOVEN, pitavastatin), CNS medications (bupropion, carbamazepine, clobazam, topiramate, morphine, donepezil, galantamine, memantine), ophthalmic products (cyclosporine emulsion for dry eye, difluprednate emulsion, brimonidine/timolol), antibiotics (ciprofloxacin/dexamethasone otic suspension), and numerous other therapeutic categories. The company operates as a subsidiary of Bora Pharmaceuticals and focuses on uninterrupted supply, quick delivery, and in-depth account and patient knowledge.

Differentiator

Problem solved

Functional benefit

Brands

• VIGAFYDE (vigabatrin) Oral Solution: Prescription medicine for infantile spasms in babies 1 month to 2 years of age
• VIGADRONE (vigabatrin)
• KYMBEE (deflazacort)
• TORPENZ (everolimus)
• KLOR-CON (Potassium Chloride)
• VOGELXO (testosterone) gel
• QUDEXY XR (topiramate)
• FORFIVO XL (bupropion)

Products and services

• Cyclosporine Ophthalmic Emulsion 0.05% Generic ophthalmic emulsion indicated to increase tear production in patients with suppressed tear production due to ocular inflammation associated with keratoconjunctivitis (dry eye). Therapeutically equivalent to AbbVie's Restasis; available in 30-count and 60-count single-use 0.4 mL vials.
• Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension Generic otic suspension combining an antibiotic (ciprofloxacin 0.3%) and corticosteroid (dexamethasone 0.1%) for treatment of ear infections. The company's first prescription ear drop suspension. Carries Therapeutic Equivalence (TE) code AB, directly substitutable for the brand drug.
• VIGAFYDE (vigabatrin) Oral Solution Prescription medicine for treatment of infantile spasms (IS) in babies 1 month to 2 years of age. First and only ready-to-use vigabatrin oral solution. Acquired from Pyros Pharmaceuticals.
• VIGADRONE (vigabatrin) for Oral Solution Prescription vigabatrin product for oral solution used to treat infantile spasms in patients 1 month to 2 years of age and refractory complex partial seizures in adults and children 2 years and older.
• VIGADRONE (vigabatrin) Tablets 500 mg vigabatrin tablets for treatment of infantile spasms and refractory complex partial seizures, available through the Vigabatrin REMS Program.
• KYMBEE (deflazacort) Tablets Corticosteroid medication for treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. Available in 6 mg, 18 mg, 30 mg, and 36 mg strengths.
• KYMBEE (deflazacort) Oral Suspension 22.75 mg/mL oral suspension formulation of deflazacort for treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. Provides flexible dosing for patients who may have difficulty swallowing tablets.
• TORPENZ (everolimus) Tablets Prescription mTOR inhibitor used to treat benign tumors associated with tuberous sclerosis complex (TSC), including subependymal giant cell astrocytoma (SEGA) and renal angiomyolipoma. Available in 2.5 mg, 5 mg, 7.5 mg, and 10 mg strengths.
• QUDEXY XR (topiramate) Extended-Release Capsules Extended-release topiramate capsules for migraine prevention and seizure disorders, available in multiple dose strengths with once-daily dosing.
• KLOR-CON (Potassium Chloride Extended-Release Tablets) Potassium chloride extended-release tablets for treatment of hypokalemia, available in multiple formulations including original formulation, new formulation (AB2), micro-dispersible technology, and powder for oral solution. One of the company's top-selling products.
• JANTOVEN (Warfarin Sodium Tablets) Anticoagulant medication for prevention and treatment of blood clots, available in multiple strengths from 1 mg to 10 mg.
• VOGELXO (Testosterone) Gel Topical testosterone replacement therapy gel for treatment of low testosterone in men, available in tube, packet, and pump formulations.
• FORFIVO XL (Bupropion Hydrochloride Extended-Release Tablets) Extended-release bupropion formulation for major depressive disorder.
• Pacerone (Amiodarone HCl) Tablets Antiarrhythmic medication for treatment of life-threatening ventricular arrhythmias, available in 100 mg and 200 mg strengths.
• VANDAZOLE (Metronidazole Vaginal Gel 0.75%) Antimicrobial vaginal gel for treatment of bacterial vaginosis, available in 70 gram tube.
• Difluprednate Ophthalmic Emulsion Ophthalmic corticosteroid emulsion for treatment of inflammation in the eye.
• Bupropion Hydrochloride Extended-Release Tablets (XL) Antidepressant medication in extended-release tablet form for treatment of major depressive disorder, available in 450 mg strength.
• Generic Pharmaceutical Portfolio (Cardiovascular, CNS, Oncology, and Other Therapies) Broad generic pharmaceutical portfolio spanning cardiovascular (diltiazem, nifedipine, atenolol/TENORMIN, lisinopril/ZESTRIL, pitavastatin), CNS (carbamazepine, clobazam, topiramate, morphine sulfate, donepezil, galantamine, memantine), oncology (sorafenib, exemestane, letrozole, bexarotene), antipsychotics (chlorpromazine, haloperidol, olanzapine), and additional therapeutic categories. Includes isotretinoin capsules distributed through the iPLEDGE REMS program.
• Promise of Support Program (KYMBEE Patient Support) Patient support program offering benefits investigation, prior authorization support, copay assistance, bridge supply, and 24/7 pharmacist access for KYMBEE (deflazacort) products used in Duchenne muscular dystrophy treatment.

Quantifiable outcome

• 6-time Brand winner or runner up for Manufacturer of the Year from McKesson
• +3 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• Pyros PharmaceuticalscoreStrategic or Co-development Partner · 1 October 2024Bora Pharmaceuticals acquired Pyros Pharmaceuticals in October 2024, enhancing Upsher-Smith's treatment offerings with the introduction of the first ready-to-use oral solution for infantile spasms (VIGAFYDE). This expanded Upsher-Smith's specialty portfolio for rare pediatric conditions.
• TWi PharmaceuticalscoreStrategic or Co-development Partner · 1 January 2024Following Bora's acquisition of Upsher-Smith, the company merged with TWi Pharmaceuticals in July 2024. This integration incorporated TWi's products into Upsher-Smith's extensive portfolio and combined TWi's specialized R&D capabilities with Upsher-Smith's commercial infrastructure.
• Tonix Pharmaceuticals Holding Corp.minorChannel Partner/ Reseller/ Distributor · 1 July 2023In July 2023, Tonix Pharmaceuticals acquired two marketed migraine therapies - Zembrace SymTouch and Tosymra - from Upsher-Smith Laboratories. This represented an asset sale/divestiture of certain product rights.
• McKessoncoreChannel Partner/ Reseller/ DistributorMajor pharmaceutical wholesale distributor relationship. Upsher-Smith has won McKesson's Manufacturer of the Year award 6 times and Representative of the Year award twice, demonstrating strong ongoing distribution partnership.
• AmerisourceBergencoreChannel Partner/ Reseller/ DistributorMajor pharmaceutical wholesale distributor relationship. Upsher-Smith has been recognized as a 5-time Sales Rep of the Year Nominee and received Supplier of the Year Award from AmerisourceBergen.
• Cardinal HealthcoreChannel Partner/ Reseller/ DistributorMajor pharmaceutical wholesale distributor and supply chain partner. Upsher-Smith has received 24 Cardinal Health Supply Chain Excellence Awards - more than any other manufacturer - and a Sales Rep of the Year Award.
• Parent Project Muscular Dystrophy (PPMD)minorGTM or Marketing PartnerUpsher-Smith participates in PPMD Annual Conference to showcase commitment to Duchenne muscular dystrophy community and provide information about KYMBEE products and support services.

Scale indicators7 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Amneal Pharmaceuticals: U.S.-focused generic and specialty pharmaceutical manufacturer with a similarly broad generics portfolio and growing branded specialty business (e.g., neurology, endocrine). Highly comparable business model and customer base to Upsher-Smith's generic + branded mix.
• Apotex: Canadian-headquartered generic pharmaceutical manufacturer with substantial U.S. operations and an active contract manufacturing platform. Comparable mix of in-house generic development plus third-party manufacturing services similar to Upsher-Smith/Bora's CDMO business.
• Lannett: U.S. generic pharmaceutical manufacturer with a multi-therapeutic-area portfolio and a focus on affordable, supply-reliable generics. Directly comparable in scale, customer base (Big-3 wholesalers), and generic-centric product strategy.
• ANI Pharmaceuticals: U.S. specialty/generic pharmaceutical company that develops, manufactures, and markets both generic and branded products, including rare-disease and niche indications. Closely matches Upsher-Smith's hybrid generics + specialty branded business model.
• Aurobindo Pharma: India-based global generic pharmaceutical manufacturer with a large U.S. generics business and active contract manufacturing capabilities. Directly comparable on U.S. generic portfolio breadth, ANDA-driven model, and CDMO orientation.
• Zydus Pharmaceuticals (Zydus Cadila): India-based pharmaceutical group with a substantial U.S. generics and specialty business. Comparable in offering broad U.S. generic coverage across multiple dosage forms (tablets, injectables, topicals) with growing specialty exposure.
• Endo Pharmaceuticals: U.S. specialty and generic pharmaceutical manufacturer with a portfolio spanning injectables, generics, and branded specialty (pain, endocrinology, urology). Comparable in combining mature generic franchises with branded specialty products targeting defined patient populations.

Broad incumbents

• Teva Pharmaceutical Industries: World's largest generic pharmaceutical manufacturer with a dominant U.S. generics business plus specialty franchises. While much larger and broader, Teva is the benchmark incumbent in U.S. generic and specialty pharma that Upsher-Smith competes against across multiple product lines.
• Sandoz: Novartis spin-off and one of the leading global generic pharmaceutical companies with significant U.S. presence. Functions as a broad incumbent in the same categories as Upsher-Smith, particularly in solid oral generics and biosimilars.

Regional players

• Sawai Pharmaceutical Holdings: Japanese generic pharmaceutical company and the prior owner of Upsher-Smith (acquired 2017, divested 2024). Operates the same hybrid generics + specialty model in Japan and is a relevant reference point for how Upsher-Smith has historically been integrated within a foreign parent's strategy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/UpsherSmithLaboratoriesLLC
• LinkedInlinkedin.com/company/upsher-smith-laboratories

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

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

M&A

Investments1 record

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

Frequently asked questions about Upsher Smith Laboratories