What OEP Pharma does

OEP Pharma is the US commercial identity of OEP Group, a publicly traded (TWSE), founder-led pharmaceutical company founded in 1982 in Taiwan by Peter Tsai. The company operates as a vertically integrated pharmaceutical platform with ~1,000 employees across 10 countries, combining (1) Asian licensing and distribution of branded pharmaceuticals via a 350+ person sales force in 7 countries (Taiwan, Hong Kong, Singapore, Malaysia, Vietnam, Indonesia, Myanmar), (2) ANDA generic products commercialized in the US through distribution partners such as PAI (e.g., Vancomycin hydrochloride capsules), (3) co-development of 505(b)(2) specialty products with partners including DURECT (Methydur / ORADUR-Methylphenidate ER) and in-licensing of late-stage assets from partners including CEL-SCI (Multikine cancer immunotherapy, 9 countries) and Supernus (Trokendi XR migraine, 7 Asian countries), and (4) CMO/CDMO and CRO/clinical-trial-operations services. Revenue is generated through licensing royalties and distribution margins on Asian branded sales, transaction-based US generic sales via channel partners, development fees and milestones from 505(b)(2) co-development, and managed-service CMO/CDMO/CRO contracts for global pharma customers.

The technical backbone is two PIC/S GMP, EU GMP, US FDA (oral-dosage) and Taiwan FDA-certified manufacturing facilities in Yunlin, Taiwan, totaling roughly 286,000 square feet (162,532 sq ft oral-dosage with 16 production suites, 30 cleanrooms, and 4 packaging lines; 123,318 sq ft injectables with fully integrated isolator for sterile fill-finish through lyophilization). Capability depth centers on complex modified-release oral solids — Multi-Phasic Release Technology (MPRT), Multi-Day Transdermal Drug Delivery (MTDD), Zero Order Release osmotic and pellet systems (OROS and PROS), and Nanoparticle Micellar Delivery — plus specialty injectables in liposomes, emulsions, suspensions, microspheres, and nanoparticles. TAA-compliance (Taiwan being a TAA-compliant country) permits direct US government sales.

The customer base is enterprise pharma: long-term Asian distribution partners (Pierre Fabre, Sanofi-Rhône-Poulenc, Chiesi, UCB, Elan/Perrigo, Teva, Kissei, Recordati) and Western co-development partners (DURECT, CEL-SCI, Supernus, Debiopharm, Plethora, Synthon, Summit Therapeutics, Tissuetech, Nanocarrier, Second Sight). The website discloses both market cap and revenue at $200MM. Strategic emphasis through 2019–2023 is North America (San Diego HQ established 2019, US FDA certification pursuit on the injectables plant) layered on top of the established Asian commercial franchise.

Name

OEP Pharma

Legal name

OEP Pharma

Website

https://oeppharma.com

Company type

Public

Founded year

1982

Operating status

Operating

Headcount range

501–1,000 employees

Short description

OEP Pharma is the US arm of Taiwan-listed OEP Group, a full-service pharmaceutical company providing Asia-Pacific licensing and distribution, US ANDA generic commercialization, 505(b)(2) co-development, and CMO/CDMO/CRO services to global pharma partners. It operates from two PIC/S-, EU GMP-, and US FDA-certified manufacturing facilities in Yunlin, Taiwan.

Ownership category

akta.pro rank

Product category

Pharmaceutical Manufacturing

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254), Drugs and Druggists' Sundries Merchant Wholesalers (424210), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

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

akta.pro primary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

akta.pro secondary industries

Contract Development & Manufacturing for Generics (CDMO/CMO) (HLAIABAI), Specialty Pharma & Biologics Distribution (GDP-compliant) (HLAGAMAD), Respiratory & Allergy Pharmaceuticals (HLAIAAAH), Small-Molecule CMC Documentation & Regulatory Support (DMF/CMC) (HLAGAHAM)

Keywords

• Generic pharmaceutical manufacturing
• Contract pharmaceutical manufacturing
• Drug delivery technology
• Pharmaceutical licensing distribution
• Specialty pharma co-development

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices12 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Licensing & Distribution of Branded Pharma in Asia: OEP serves as commercial partner for global pharmaceutical companies, distributing branded products through their extensive Asian sales networks. Revenue comes from licensing fees, distribution margins, and milestone payments.
2. ANDA Products (Generic Pharmaceuticals): Manufacturing and marketing generic pharmaceutical products in the US and select markets through commercial distributors. Revenue from product sales through distribution partners.
3. Co-development of 505(b)(2)s: Co-development of specialty pharmaceutical products with partners, providing financial resources, technology, and manufacturing capacity. Revenue from development fees, regulatory milestones, and product commercialization.
4. CMO/CDMO/CRO Services: Contract manufacturing and development services for oral dosage and injectable products. Services include analytical method development, clinical trial management, quality control, and compendial testing.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels4 records

Core offering

OEP Pharma is a full-service global pharmaceutical company that develops, manufactures, and distributes drug products across North America and Asia-Pacific. Its operations span ANDA generic manufacturing, 505(b)(2) specialty co-development, branded pharmaceutical licensing and distribution in Asia through 350+ person sales teams, and CMO/CDMO/CRO services executed from two FDA-certified, PIC/S GMP-compliant facilities in Yunlin, Taiwan.

Product overview

OEP Pharma is a full-service pharmaceutical company offering a unified platform spanning drug development, manufacturing, and commercial distribution. Its product portfolio consists of three core pillars: (1) a growing ANDA portfolio of generic pharmaceuticals (immediate-release and controlled-release products including Vancomycin, Carisoprodol, Miglitol, Glyburide, Pitavastatin, Ezetimibe, Rivastigmine), all manufactured in TAA-compliant Taiwan; (2) a 505(b)(2) pipeline of specialty pharma products co-developed with partners such as DURECT (ORADUR-Methylphenidate ER / Methydur for ADHD) and in-licensed from companies such as CEL-SCI (Multikine, cancer immunotherapy) and Supernus Pharmaceuticals (Trokendi XR, CNS/migraine); and (3) CMO/CDMO and CRO services including oral dosage manufacturing (complex modified-release), cytotoxic injectables manufacturing, analytical services, clinical trial operations, and commercialization across Asia. These capabilities are interconnected: OEP manufactures its own portfolio while also offering manufacturing as a service to partners, and leverages its sales networks to distribute both self-manufactured and in-licensed products across North America and Asia-Pacific.

Differentiator

Problem solved

Functional benefit

Products and services

• ANDA Generic Pharmaceutical Portfolio Out-licensed and distributed generic pharmaceuticals (ANDA products) for the US market via commercial distributors such as PAI, manufactured at OEP's FDA-certified facilities in Yunlin, Taiwan.
• 505(b)(2) Specialty Pharmaceutical Pipeline Specialty pharmaceutical products developed via the 505(b)(2) regulatory pathway, co-developed with partners such as DURECT, with some marketed in Taiwan.
• Vancomycin Hydrochloride Capsules An antibiotic generic medication marketed in the U.S. via out-licensing partner PAI (Pharmaceutical Associates, Inc.), part of OEP's ANDA portfolio.
• ORADUR-Methylphenidate ER / Methydur A 505(b)(2) ADHD drug co-developed with DURECT using ORADUR technology; OEP holds development and commercialization rights in 14 Asian and South Pacific countries and it is approved and commercially launched in Taiwan.
• Multikine CEL-SCI's lead investigational cancer immunotherapy drug, exclusively in-licensed by OEP for distribution in 9 countries.
• Trokendi XR A CNS drug that helps prevent migraines, in-licensed from Supernus Pharmaceuticals and launched in 7 Asian countries.
• Branded Asia Pharmaceutical Portfolio Branded pharmaceutical products marketed across Asian markets including Zulitor, Trokendi, Pitator, Navelbine, Methydur, and others covering cardiovascular, neurology, diabetes, respiratory, and oncology treatments.
• Injectables Manufacturing (Cytotoxic Oncology) Contract manufacturing of cytotoxic injectable oncology products using fully integrated isolators for sterile production from filling to lyophilization, supporting liposomes, emulsions, suspensions, microspheres, and nanoparticles delivery platforms from a 123,318 square foot PIC/S GMP-certified facility in Yunlin, Taiwan.
• Oral Dosage Manufacturing Contract manufacturing of complex modified-release oral dosage forms from a 162,532 square foot PIC/S GMP, EU GMP, Taiwan and US FDA-certified facility in Yunlin, Taiwan, with 16 production suites, 30 cleanrooms, and 4 packaging lines.
• CMO/CDMO Services Integrated contract manufacturing and development services for oral dosage and injectable products, including analytical method development and validation, quality control, and compendial testing (USP, BP, EP, JP), from FDA-certified, PIC/S GMP facilities in Taiwan.
• CRO / Clinical Trial Operations Services Agile clinical trial research services including site selection, trial management, and delivery of high-quality clinical data in Asia (Taiwan, Singapore, Korea), Australia, and New Zealand.
• Licensing and Distribution Services (Branded Pharma in Asia) Commercial licensing and distribution of branded pharmaceutical products across Asia, leveraging nearly 40 years of local regulatory expertise and 350+ person sales teams in 7 countries.
• 505(b)(2) Co-Development Services Co-development partnerships for 505(b)(2) specialty pharmaceutical products, providing financial resources, proprietary drug delivery technology, and manufacturing capacity to bring specialty pharmaceuticals to market.

Named customers8 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

18 partnerships are on record, tiered core, flagship and minor.

• DURECT CorporationcoreStrategic or Co-development Partner · 1 January 2009In 2009, DURECT granted OEP the development and commercialization rights to ORADUR-Methylphenidate ER Capsule (Methydur Sustained Released Capsules), its lead ORADUR-ADHD program, in 14 Asian and South Pacific countries. Together, OEP and DURECT developed a lead formulation based on clinical trial research. OEP oversaw phase III clinical trials in Taiwan, handles manufacturing, and has received or is pursuing regulatory approvals in 14 countries including Australia and New Zealand.
• PAI (Pharmaceutical Associates, Inc.)coreChannel Partner/ Reseller/ DistributorOEP's ANDA portfolio provides high-quality generic medications at affordable prices. With commercial partner PAI, they launched Vancomycin hydrochloride capsules, a commonly used antibiotic, into the US market. PAI distributes the product through their North American distribution network.
• CEL-SCI CorporationcoreStrategic or Co-development PartnerCEL-SCI is a pioneer in cancer immunotherapy drugs. OEP has an exclusive licensing agreement for Multikine, CEL-SCI's lead investigational therapy. OEP invested in CEL-SCI, funded a portion of Multikine's nine-year Phase III clinical trial, and obtained licensing rights to distribute Multikine in nine countries. The global Phase 3 study has ended and is in the data analysis stage. It is believed to be the largest head and neck cancer clinical study ever conducted.
• Supernus PharmaceuticalscoreChannel Partner/ Reseller/ DistributorOEP partnered with Supernus Pharmaceuticals to launch Trokendi XR, a CNS drug that helps prevent migraines, in 7 Asian countries. OEP leverages their local sales teams and regulatory expertise to commercialize the product in the region.
• Pierre FabreflagshipChannel Partner/ Reseller/ DistributorPierre Fabre is a long-standing commercial partner of OEP for branded pharmaceutical distribution in Asia. OEP has been the commercial partner of choice for Pierre Fabre for nearly 40 years, helping them access Asian markets including Taiwan and ASEAN countries.
• Sanofi (Rhône-Poulenc)flagshipChannel Partner/ Reseller/ DistributorSanofi's Rhône-Poulenc division was one of OEP's early major commercial distribution partners, establishing the company's reputation as the regional distributor of choice in the 1980s and 1990s.
• ChiesicoreChannel Partner/ Reseller/ DistributorChiesi partnered with OEP for licensing of respiratory products in Asian markets. OEP secured licensing deals to expand Chiesi's respiratory product portfolio into the Asian region through their established sales networks.
• UCBcoreChannel Partner/ Reseller/ DistributorUCB partnered with OEP for licensing of their CNS portfolio in Asian markets. OEP led the expansion of sales into Asian markets for UCB's central nervous system products through their commercial network.
• Elan (Perrigo)flagshipChannel Partner/ Reseller/ DistributorElan (now part of Perrigo) was an early commercial distribution partner for OEP, helping establish the company's credentials as a premier distributor for European pharmaceutical companies entering Asian markets.
• DebiopharmminorStrategic or Co-development PartnerListed as a partner on the Partners and Results page, indicating a commercial or licensing relationship for pharmaceutical products.
• PlethoraminorStrategic or Co-development PartnerListed as a partner on the Partners and Results page, indicating a commercial or licensing relationship for pharmaceutical products.
• RecordatiminorChannel Partner/ Reseller/ DistributorListed as a partner on the Partners and Results page, indicating a commercial or licensing relationship for pharmaceutical products.
• Second SightminorStrategic or Co-development PartnerListed as a partner on the Partners and Results page, indicating a commercial or licensing relationship for pharmaceutical products.
• SYNTHONminorStrategic or Co-development PartnerListed as a partner on the Partners and Results page, indicating a commercial or licensing relationship for pharmaceutical products.
• Kissei PharmaceuticalminorChannel Partner/ Reseller/ DistributorListed as a partner on the Partners and Results page, indicating a commercial or licensing relationship for pharmaceutical products.
• Summit TherapeuticsminorStrategic or Co-development PartnerListed as a partner on the Partners and Results page, indicating a commercial or licensing relationship for pharmaceutical products.
• TissuetechminorChannel Partner/ Reseller/ DistributorListed as a partner on the Partners and Results page, indicating a commercial or licensing relationship for pharmaceutical products.
• Teva PharmaceuticalminorChannel Partner/ Reseller/ DistributorListed as a partner on the Partners and Results page, indicating a commercial or licensing relationship for pharmaceutical products.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• WuXi AppTec: China-based global CRO/CDMO with significantly larger scale than OEP; competes for CMO/CDMO contracts in injectable and oral dosage manufacturing from Asia.
• Pierre Fabre: French specialty pharma (dermo-cosmetics, oncology, CNS) — flagship OEP licensing partner of 40 years; comparable specialty pharma profile and shared Asia distribution economics.
• Catalent: Global CDMO with broad oral, injectable, and specialty delivery capabilities; competes with OEP for Western pharma CMO/CDMO contracts, though at much larger scale.
• Chiesi Farmaceutici: Italian specialty pharma (respiratory, rare disease) — OEP licensing partner for respiratory products in Asia; comparable European specialty pharma leveraging OEP-like regional distribution.

Direct peers

• Bora Pharmaceuticals: Taiwan-based CDMO with FDA/EU GMP-certified facilities offering oral dose and injectable manufacturing plus specialty distribution — the closest comparable to OEP's integrated platform in scale and geography.
• DURECT Corporation: US specialty pharma using proprietary drug delivery platforms (ORADUR) — co-development partner with OEP for Methydur; directly comparable modified-release technology and licensing-out model.
• Lotus Pharmaceutical: Taiwan-headquartered specialty generics company with strong Asian distribution and 505(b)(2)-style product development — overlaps OEP's Asian commercial platform and modified-release portfolio.
• ScinoPharm Taiwan: Taiwan-based API and injectable manufacturer with global CDMO services and ANDA generics; directly comparable to OEP's Taiwan manufacturing footprint and regulated-market generics pipeline.
• Formosa Pharmaceuticals: Taiwan-based specialty pharma developing ophthalmic and oncology products with Asia-focused commercialization — comparable specialty-pharma strategy and Taiwan R&D/manufacturing base.
• Supernus Pharmaceuticals: US CNS specialty pharma whose products (Trokendi XR, etc.) are licensed to OEP for Asia; similar modified-release CNS focus and partner-driven geographic expansion model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/oep-pharma

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries1 record

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 OEP Pharma