Business Details
12 Years
experience
Your Trusted Specialty Pharmaceutical Partner
Handa Pharma is a specialty pharmaceutical company dedicated to developing and commercializing high-quality prescription medications that address significant unmet patient needs. Our entrepreneurial spirit and technical expertise drive our focus on intellectual property innovation and problem-solving in pharmaceutical development. With a proven leadership team, we manage all aspects of product development through FDA submissions via four wholly-owned subsidiaries specializing in generics, neuroscience, oncology, and proprietary therapeutics.Our proprietary ONCORE technology platform enhances bioavailability for clinically differentiated Tyrosine Kinase Inhibitors (TKIs) in oncology applications. We maintain a successful partnering model through co-development and out-licensing strategies to build long-term value for stakeholders.
Services
Generic Drug Development
Oncology Therapeutics
Proprietary Formulations
FDA Regulatory Submissions
ANDA Filings
505(b)(2) Applications
Drug Delivery Technology
Pharmaceutical Partnerships
Quality Assurance
Clinical Development
Details
- Year established: 2014
Highlights and features
- We offer 20+ years of pharmaceutical development expertise with FDA-approved products
- Our proprietary ONCORE technology enhances drug bioavailability for oncology applications
- We specialize in complex ANDA and 505(b)(2) regulatory submissions
- Our leadership team has commercialized over 25 pharmaceutical products
- We maintain global partnerships for collaborative drug development
Services
Generic Drug Development
We specialize in developing high-barrier generic medications through rigorous formulation and process optimization. Our expertise includes ANDA submissions and commercial scale production. Our team has successfully developed first-to-file generic products with complex formulations.
Oncology Therapeutics
Our oncology division focuses on developing targeted therapies using our proprietary ONCORE technology platform. This innovative approach enhances bioavailability and reduces pharmacokinetic variability in Tyrosine Kinase Inhibitors for improved patient outcomes.
FDA Regulatory Submissions
We manage complete regulatory processes for Abbreviated New Drug Applications and 505(b)(2) New Drug Applications. Our team has secured multiple FDA approvals for complex generic and branded medications through strategic submissions.
Drug Delivery Technology
Our ONCORE technology platform creates clinically differentiated drug delivery systems. This proprietary solubility enhancement technology improves bioavailability while eliminating food and PPI restrictions for better patient compliance.
Pharmaceutical Partnerships
We establish strategic partnerships through co-development and out-licensing models. Our collaborative approach focuses on building long-term value through shared expertise in pharmaceutical innovation and commercialization.
People
Bill Liu
President and Chief Executive Officer
Dr. Liu has over 20 years of pharmaceutical leadership experience, founding Handa in 2005. He previously built Anchen Pharmaceuticals' operations and developed generic controlled-release products at Impax and Watson Pharmaceuticals.
Maggie Chang
Executive Vice President Quality Affairs
Dr. Chang brings 20+ years of quality assurance expertise, including FDA-approved ANDA submissions at Anchen Pharmaceuticals. She previously managed analytical departments at Impax Laboratories with extensive controlled substances experience.
Li Qiao
SVP Program Management & Regulatory Affairs
Dr. Qiao has led analytical services at Handa since 2010 with 16 years pharmaceutical experience. She previously held roles at 3M's Drug Delivery Division and Impax Laboratories, specializing in method validation.
Michael He
Vice President Product Development
Dr. He has over 20 years of product development experience, leading Handa's tech-transfer efforts since 2009. He previously managed client portfolios at UPM Pharmaceuticals and worked at Bayer and Yamanouchi.
David Quiggle
Vice President Regulatory Affairs
Mr. Quiggle brings 30 years pharmaceutical experience including 25 years in regulatory affairs. He has secured FDA approvals for complex generics and held leadership roles at Hikma, Amerigen, and Par Pharmaceuticals.
Questions
What therapeutic areas does Handa Pharma specialize in?
We focus on oncology therapeutics through our proprietary ONCORE™ technology and high-barrier generic medications across various therapeutic categories.
What makes Handa's drug development approach unique?
Our proprietary ONCORE™ technology platform enhances drug bioavailability while eliminating food and PPI restrictions for improved patient compliance.
How does Handa handle regulatory submissions?
We manage complete FDA regulatory processes including ANDA filings and 505(b)(2) applications with a proven track record of approvals.
What partnership models does Handa utilize?
We employ co-development and out-licensing models to create collaborative drug development opportunities that build long-term value.
Where is Handa Pharma headquartered?
Our headquarters are located at 2025 Gateway Place, Suite 480, San Jose, CA 95110 in the San Francisco Bay Area.
