Optimize People's Lives
About us
OPL is a leader in developing NDA products through the 505(b)(2) pathway, leveraging proprietary timed-release, once-daily (QD) oral drug delivery, and oral peptide delivery platforms to extend patent protection, enhance NCE developability, and create differentiated products. Through a strategic portfolio management approach, OPL improves therapeutic efficacy, reduces adverse effects, enhances patient compliance, and strengthens intellectual property value to drive both clinical and commercial success.
Founded in 2011, OPL operates across three locations: San Diego, California; Guangzhou, China; and Taizhou, China. The company maintains 150,000 square feet of integrated facilities, including R&D laboratories and pilot plants operating under cGMP conditions at all three sites, as well as a cGMP commercial manufacturing facility in Guangzhou, China. OPL’s San Diego site holds a Drug Enforcement Administration (DEA) manufacturer’s license for the handling and manufacturing of controlled substances classified under Schedules III–V.
Vision-To advance drug delivery science and become a global leader in innovative drug delivery technologies and 505(b)(2) pharmaceutical products.
Mission-To develop safer, more effective, and patient-centered medicines that address unmet medical needs and improve lives.
Our Focus
Develop innovative pharmaceutical products that improve therapeutic outcomes and address unmet medical needs.
Partner with pharmaceutical companies to create differentiated products using OPL’s proprietary drug delivery platforms.
Advancing drug delivery and enhancing patient care.
Our Core Values
Patients First
We place patients at the center of everything we do, focusing on therapies that improve outcomes and quality of life.
Innovation
We challenge conventional thinking and pursue scientific excellence to create meaningful healthcare solutions.
Ownership
We take initiative, embrace accountability, and are committed to delivering results.
Courage
We approach challenges with determination, make bold decisions, and pursue opportunities that drive progress.
Integrity
We uphold the highest ethical standards and conduct our business with honesty, transparency, and trust.
Key Therapeutic Areas
Pain Management
Insomnia and Sleep Disorders
Cardiovascular Diseases
Metabolic Diseases
Central Nervous System (CNS) Disorders
Autoimmune Diseases
Idiopathic Pulmonary Fibrosis (Respiratory)
Our Goals
Improve Patients’ Lives
Develop innovative medicines and drug delivery technologies that address real-world healthcare challenges.
Create Long-Term Shareholder Value
Drive sustainable growth through scientific innovation, operational excellence, and strategic execution.
Invest in Our People
Provide opportunities for employees to grow, lead, and achieve their full potential.
Foster Employee Well-Being
Support a rewarding workplace that promotes professional success, financial security, and personal fulfillment.
50+INDs approved by FDA
20+Patents
2+Phase III clinical trials
13+Phase I clinical trials
Our Technology
OPL's proprietary controlled-release technologies enable the development of differentiated NDA products for both New Chemical Entities (NCEs) and life-cycle management programs.
New Chemical Entity (NCE) Development – NDA under 505(b)(1)
Our proprietary technologies can be integrated early in development to directly formulate NCEs as controlled-release products, creating differentiated therapies with optimized pharmacokinetic (PK) profiles.
By precisely controlling drug release, our platforms can:
Reduce peak plasma concentration (Cmax) while maintaining overall exposure (AUC).
Increase AUC without increasing Cmax when efficacy is driven by drug exposure and toxicity is associated with peak concentration.
Improve the druggability of challenging compounds by enhancing the balance between efficacy and tolerability.
Enable differentiated products with clinically meaningful advantages.
Provide opportunities for additional intellectual property protection and product differentiation, potentially extending the commercial life of an NCE.
Life-Cycle Management – NDA under 505(b)(2)
Our controlled-release technologies can also be applied to marketed products to create improved formulations through the 505(b)(2) regulatory pathway.
These reformulations can:
Enhance therapeutic efficacy through optimized PK profiles.
Reduce adverse effects associated with high peak drug concentrations.
Improve patient adherence by enabling more convenient dosing regimens.
Differentiate existing products while extending their product life cycle.
Optimized Pharmacokinetic Profiles
The pharmacokinetic profiles shown below demonstrate the capabilities of our proprietary controlled-release technologies to tailor drug exposure, optimize Cmax and AUC, and support the development of differentiated products with improved therapeutic performance.
Pipeline
Product Pipeline in Various Therapeutic Areas at Different Clinical Stages
Category
Product
Indication
Pre-clinical
IND
Phase I
Phase III
Pain management
OPL-015
General pain
OPL-054
General pain
OPL-055
General pain
OPL-056
General pain
OPL-004
General pain
OPL-053
Pain-induced insomnia
Cardiovascular disease
OPL-009
Morning surge
OPL-034
Venous thrombosis
OPL-085
Heart failure
OPL-022
Morning surge
CNS
OPL-032
Insomnia
OPL-026
Epilepsy
OPL-044
Epilepsy
OPL-020
Depression
Autoimmune diseases
OPL-042
Rheumatoid arthritis
OPL-029
Psoriatic arthritis
Respiratory diseases
OPL-040
IPF
Metabolic diseases
OPL-025
Diabetes
OPL-028
Diabetes
Our team
Founder, CEO, and CTO
Gilbert Wen, Ph.D.
Chief Strategy Officer
Danchen Gao, Ph.D.
Head, Operation and Medical Affairs
Maggie Lu, M.D.
Head, Clinical Operation and International BD
Bruce Cai, Ph.D.
Head, Corporate Finance
Leon Liao, M.S.
Head, HR
Apple Yuan
Head, Regulatory Affairs
Annie Zhang, Ph.D.
Head, QA
Jean Wang, Ph.D.
Head, IP Strategy
Azura Zhang, M.S.
Head, BD
Lily Chang, M.S.
Head, Production & Operations
Julia Zhu
Head, Project Management
Serena Shi, M.S.
Manager, Global BD
Bryce Babcock
Manager, Global BD
Gadisa Musa, M.D., M.S.
Locations
OPL maintains integrated research, development, and manufacturing operations across the U.S. and China. Together, these facilities provide seamless support from formulation development and clinical supply manufacturing to commercial-scale production.
Contact us
Products
Approved by FDA
Approved by NMPA
Approved by NMPA
Equipment and Instruments
Career
How We Work
Find a Way Forward
We are resourceful, resilient, and solution-oriented. Obstacles are opportunities to innovate.
Execute with Excellence
We maintain high standards, move with purpose, and deliver on our commitments.
Join Our Team
At OPL, innovation starts with people.
We are seeking talented scientists, engineers, and professionals who are passionate about advancing pharmaceutical development and improving patient outcomes. With world-class equipment, proprietary drug delivery technologies, and a collaborative culture, OPL offers opportunities to learn, grow, and make a lasting impact.
Build your career Advance innovation Improve livesGeneral Manager, U.S. Formulation CRO Subsidiary
Oversee all local operations, source formulation development clients whose projects are initially executed by China headquarters, and build local capabilities to independently deliver R&D projects long-term.
Contact Email: contact@oplpharm.com
Manager, Clinical Operation
Screen and select clinical CROs to conduct llT, PK studies, and efficacy studies. Communicate study objectives to clinical CROs and review clinical protocols. Lead and oversee the execution of clinical trials. Compile clinical results into NDA application dossier.
Contact Email: contact@oplpharm.com
Manager, Global Regulatory Affairs
Coordinate with different departments to acquire development reports including formulation, analytical, and clinical trial materials for NDA or ANDA submissions to agencies including US FDA, EU EMA, Japan PMDA, and China NMPA. Communicate with regulatory agencies to inguire about approval progress, answer questions, and coordinate internal responses to deficiency letters. Answer questions from intemal teams and provide training on updates to regulatory guidelines.
Contact Email: contact@oplpharm.com
Partner with OPL
Product Licensing
OPL offers licensing opportunities for both innovative and generic pharmaceutical products.
Innovative Drug Products
Available for licensing at various stages of development, including:
IND-ready, phase I to phase III programs
Clinical pharmacokinetic (PK) stage programs with target PK profiles achieved
Clinical efficacy stage programs that have met primary and secondary study endpoints
Product Licensing
OPL offers licensing opportunities for both innovative and generic pharmaceutical products.
Proprietary Timed-Release Technologies
OPL's advanced drug delivery platforms enable pharmaceutical companies to enhance product performance and extend product lifecycles.
Product Lifecycle Extension
Conversion of immediate-release (IR) products into controlled-release (CR) formulations
Development of differentiated, next-generation products
Strong platform IP protection
New Chemical Entity (NCE) Formulation Enhancement
Our technologies can help:
Reduce dosing frequency
Improve patient compliance
Minimize peak-to-trough plasma concentration fluctuations
Reduce dose-related adverse effects
Enhance overall product performance
Proprietary Timed-Release Technologies
OPL's advanced drug delivery platforms enable pharmaceutical companies to enhance product performance and extend product lifecycles.
Complex Generics & Product Differentiation
Alternative Formulation Technologies for ANDA Development
Innovative formulation approaches that support robust, regulatory-compliant ANDA submissions and efficient product development.
Patent Circumvention for First-to-File Opportunities
Strategic formulation and development solutions designed to navigate patent barriers and enable first-to-file market opportunities.
Controlled-Release Platform Solutions
Advanced modified- and controlled-release technologies for the successful development of complex generic products.
Competitive Product Differentiation Strategies
Tailored solutions that enhance product performance, strengthen market positioning, and maximize commercial success throughout the product lifecycle.
Complex Generics & Product Differentiation
Strategic Partnerships
We collaborate with a wide range of pharmaceutical and healthcare organizations.
Our flexible partnership models support licensing, co-development, technology transfer, and commercialization initiatives.
Contract Manufacturing Organizations (CMOs)
Specialty pharmaceutical companies
Multinational pharmaceutical companies
Generic pharmaceutical manufacturers
Emerging biotech and specialty drug developers
Strategic Partnerships
We collaborate with a wide range of pharmaceutical and healthcare organizations.
Innovative Formulation & CMC Services
Powered by our proprietary technology, we specialize in solving complex formulation challenges, enabling rapid progression from preclinical research through clinical development.
Preclinical formulation development
IND-enabling studies
Clinical trial material manufacturing
Phase I, Phase II, and Phase III clinical development CMC support
Innovative Formulation & CMC Services
IND-enabling formulation development to support emerging biotech and small-molecule innovators.
Contact
Why Partner with OPL?
- Proven expertise in proprietary timed-release drug delivery technologies
- Experience supporting 505(b)(2), NDA, IND, and ANDA programs
- Integrated capabilities spanning R&D, clinical development, regulatory support, and GMP manufacturing
- Flexible partnership models for licensing, co-development, and contract services
- Global operations in the U.S. and China supporting efficient product development and commercialization
OPL Pharmaceuticals
Address: 6323 Nancy Ridge Drive, San Diego,
California USA 92121
Email: bryce_babcock@oplpharm.com
Phone: (+1) 650-388-9210