Handa Pharmaceuticals

What Handa Pharmaceuticals does

Handa Pharmaceuticals is a specialty pharmaceutical company founded in November 2005 by Bill Liu, Ph.D. and headquartered in San Jose, California, with the corporate parent Handa Pharmaceuticals, Inc. publicly listed in Taiwan under ticker 6620.TWO since 2014. The company develops and commercializes prescription medications through two complementary approaches: proprietary therapeutics addressing significant unmet patient needs (primarily via the 505(b)(2) regulatory pathway) and high-barrier-to-entry generic drugs (via ANDAs). It operates through four wholly-owned US subsidiaries — Handa Pharmaceuticals, LLC (generics), Handa Neuroscience, LLC, Handa Oncology, LLC, and Handa Therapeutics, LLC — and maintains R&D centers in Hangzhou, China and Tainan, Taiwan.

The product portfolio centers on two proprietary FDA-approved brands — PHYRAGO (dasatinib) tablets for Philadelphia chromosome-positive CML and ALL, acquired from Nanocopoeia in January 2025 for $30 million, and TASCENSO ODT in neurology — together with generics including dexlansoprazole delayed-release capsules and quetiapine fumarate extended-release tablets. Core technology platforms include ONCORE™, a proprietary drug delivery technology that creates clinically differentiated Tyrosine Kinase Inhibitor formulations allowing co-administration with gastric acid-reducing agents, and FlexDose® for orally disintegrating and modified-release tablets. PHYRAGO benefits from Orphan-Drug Designation with data exclusivity through December 5, 2026 (potentially extending to December 5, 2030) and Orange Book-listed patents running to January 22, 2041.

Handa's commercial model is partner-driven: specialty pharmacy distribution flows through Onco360, McKesson, Cencora, and Cardinal Health, with Cycle Pharmaceuticals serving as the primary US commercialization partner for PHYRAGO and TASCENSO ODT and Par Pharmaceutical distributing the generic portfolio. The company supplements this with co-development and out-licensing partnerships as a secondary revenue stream. Customer concentration is therefore high by design — a small number of channel partners carry the bulk of commercial execution — while the addressable opportunity is anchored by the $1.44 billion 2023 SPRYCEL market that PHYRAGO targets with a differentiated clinical profile.

Name

Handa Pharmaceuticals

Legal name

Handa Pharma, Inc.

Website

https://handapharma.com

Company type

Public

Founded year

2005

Operating status

Operating

Headcount range

11–50 employees

Short description

Handa Pharmaceuticals is a specialty pharmaceutical company developing proprietary therapeutics and high-barrier-to-entry generic drugs through FDA-approved pathways, serving oncology, neurology, and gastrointestinal patient populations across the US, Taiwan, and China via four wholly-owned subsidiaries.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

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

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Specialty Care Pharmaceuticals (HLAIAAAB)

akta.pro secondary industries

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC), Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF), Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)

Keywords

• Specialty pharmaceuticals
• Oncology therapeutics
• High-barrier generics
• Drug delivery technology
• Prescription medications

Headquarters

HQ city

Fremont

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Proprietary Therapeutics: Development and commercialization of proprietary prescription medications addressing significant unmet patient needs in oncology and neurology through 505(b)(2) New Drug Applications.
2. High-barrier-to-entry Generic Drugs: Development and commercialization of difficult-to-formulate generic pharmaceuticals through Abbreviated New Drug Applications (ANDA) submission to FDA.
3. PHYRAGO (dasatinib) Product: FDA approved chronic myeloid leukemia treatment acquired from Nanocopoeia, LLC. Currently selecting U.S. commercialization partner with expected availability in Q1-2025. Represents first and only dasatinib product that can be co-administered with gastric acid-reducing agents.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Handa Pharmaceuticals develops and commercializes specialty prescription medications through two complementary approaches: proprietary therapeutics addressing significant unmet patient needs in oncology and neurology (via 505(b)(2) NDAs) and high-barrier-to-entry generic drugs (via ANDAs). The company operates through four wholly-owned US subsidiaries covering generics, neuroscience, oncology, and therapeutics, with proprietary ONCORE and FlexDose technology platforms supporting its product portfolio.

Product overview

Handa Pharmaceuticals is a specialty pharmaceutical company operating through four wholly-owned subsidiaries: Handa Pharmaceuticals, LLC (generics), Handa Neuroscience, LLC (owner of TASCENSO ODT), Handa Oncology, LLC (oncology focus), and Handa Therapeutics, LLC (owner of PHYRAGO). The company develops and commercializes prescription medications through two complementary approaches: proprietary therapeutics addressing unmet patient needs and high-barrier-to-entry generic drugs. Core technology platforms include ONCORETM (proprietary TKI drug delivery technology) and FlexDose® (oral solid MR and ODT technology). The FDA-approved portfolio includes PHYRAGO (dasatinib) for leukemia, TASCENSO ODT for neurology, and generic products including dexlansoprazole and quetiapine fumarate.

Differentiator

Problem solved

Functional benefit

Brands

• PHYRAGO™: FDA approved dasatinib tablets for chronic myeloid leukemia (CML) treatment - the first and only dasatinib product that can be co-administered with gastric acid-reducing agents
• TASCENSO ODT®
• ONCORETM

Products and services

• PHYRAGO (dasatinib) Tablets FDA-approved chronic myeloid leukemia treatment for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who no longer benefit from or tolerate other treatments. The first and only dasatinib product that can be safely co-administered with gastric acid-reducing agents (proton pump inhibitors and H2 receptor antagonists).
• TASCENSO ODT FDA-approved neurology medication owned by Handa Neuroscience, LLC subsidiary. Indicated for treatment of neurological conditions such as multiple sclerosis. Distributed by Cycle Pharmaceuticals.
• Dexlansoprazole Delayed-Release Capsules FDA-approved generic proton pump inhibitor for treatment of gastrointestinal conditions requiring acid suppression. Distributed through Par Pharmaceutical partnership arrangement under Handa's filings.
• Quetiapine Fumarate Extended-Release Tablets FDA-approved generic extended-release antipsychotic. Also approved by Health Canada (ANDS in Partner's name). Distributed through Par Pharmaceutical partnership arrangement under Handa's filings.

Named customers6 records

Segments3 records

Ideal customer profiles2 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.

• Nanocopoeia, LLCcoreStrategic or Co-development Partner · 15 January 2025Nanocopoeia, LLC developed PHYRAGO (dasatinib) tablets, which Handa Therapeutics, LLC acquired. PHYRAGO is an FDA approved chronic myeloid leukemia treatment representing the first and only dasatinib product that can be co-administered with gastric acid-reducing agents.
• Cycle PharmaceuticalscoreChannel Partner/ Reseller/ Distributor · 15 January 2025Cycle Pharmaceuticals partnered with Handa Therapeutics, LLC for the launch of PHYRAGO (dasatinib) tablets in the US market. Cycle Pharmaceuticals handles marketing and distribution of PHYRAGO and TASCENSO ODT products.
• Onco360minorChannel Partner/ Reseller/ Distributor · 15 January 2025Specialty pharmacy distributor for PHYRAGO (dasatinib) tablets in the US market as part of the commercial launch partnership with Cycle Pharmaceuticals.
• McKessonminorChannel Partner/ Reseller/ Distributor · 15 January 2025Major pharmaceutical distributor distributing PHYRAGO (dasatinib) tablets in the US market as part of the specialty pharmacy distribution network.
• CencoraminorChannel Partner/ Reseller/ Distributor · 15 January 2025Pharmaceutical distribution services provider for PHYRAGO (dasatinib) tablets distribution in the US market.
• Cardinal HealthminorChannel Partner/ Reseller/ Distributor · 15 January 2025Pharmaceutical distribution services provider for PHYRAGO (dasatinib) tablets distribution in the US market.
• Par PharmaceuticalcoreChannel Partner/ Reseller/ DistributorPar Pharmaceutical is a partner for FDA approved products including Dexlansoprazole Delayed-Release Capsules and Quetiapine Fumarate Extended-Release Tablets distributed under Handa's filings.

Scale indicators3 records

Recent moves8 records

Expansion highlights5 records

Direct peers

• Eagle Pharmaceuticals: Specialty pharma with oncology and CNS focus that develops reformulated versions of existing molecules with clinical differentiation — directly analogous to Handa's PHYRAGO reformulation strategy and ONCORETM platform. Comparable business model of taking approved molecules and creating differentiated specialty versions.
• Cumberland Pharmaceuticals: Small-cap specialty pharma with branded prescription products across multiple therapeutic areas, focused on differentiated formulations — comparable in scale and business model to Handa's specialty pharma approach with multiple niche products.
• Cycle Pharmaceuticals: Specialty pharma focused on reformulating existing medicines for rare diseases and neurology — Handa's distribution and marketing partner for both PHYRAGO and TASCENSO ODT, with overlapping patient populations (MS, rare disease) and a comparable lifecycle management strategy.
• Supernus Pharmaceuticals: Specialty pharma focused on CNS/neurology with proprietary extended-release and ODT technologies — directly comparable to Handa Neuroscience's TASCENSO ODT (multiple sclerosis) and FlexDose ODT platform. Both target underserved CNS patients with formulation-differentiated products.
• ANI Pharmaceuticals: Specialty generics and branded specialty pharma company that focuses on high-barrier-to-entry products through ANDAs and 505(b)(2) NDAs — directly comparable to Handa Pharmaceuticals LLC's generic business model and 505(b)(2) proprietary therapeutics approach.
• Par Pharmaceutical: Specialty generics company that is Handa's distribution partner for dexlansoprazole and quetiapine fumarate products. Operates a similar high-barrier generics strategy and is comparable as a distribution/marketing partner model peer.
• Lannett Company: Small-cap specialty generics manufacturer with focus on difficult-to-formulate products — directly comparable business model to Handa Pharmaceuticals LLC's high-barrier-to-entry generic strategy.

Broad incumbents

• Amneal Pharmaceuticals: Larger specialty generics and branded specialty pharma player with Affyxia and AvKARE segments — operates in the same high-barrier generic and specialty branded space as Handa but at materially greater scale.
• Hikma Pharmaceuticals: Global specialty generics and branded pharma company with established US specialty footprint — David Quiggle (Handa VP Regulatory) previously held regulatory leadership at Hikma after the Custopharm acquisition, indicating direct overlap in talent and business model.
• Endo International: Specialty pharma with branded and generics segments including neurology and oncology — overlapping with Handa's specialty pharma focus across CNS and oncology categories, though at substantially larger scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/handa-pharmaceuticals

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries4 records

Funding overview

Funding rounds1 record

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 Handa Pharmaceuticals