TPP CDMO
CDMO Services Analytical Testing About Team Discuss your program
CDMO Services Analytical Testing About Team Contact us →
US-BASED PHARMACEUTICAL CDMO — SAN DIEGO, CA

From molecule to U.S. market.

Formulation development, sterile manufacturing, and commercial launch at an FDA-inspected, DEA-registered facility with three decades of manufacturing history.

Tell us about your molecule View capabilities
RESPONSE WITHIN ONE BUSINESS DAY · CLIENT SPONSORED AUDITS
FACILITY AT A GLANCE
FDA inspectionPassed · Jan 2023
DEA registrationsSch. IV · V
Potency capabilitySafeBridge ≤ Cat 3A
cGMP footprint24,400 sq ft
Dosage formsMulti-form, incl. sterile
WAYS TO ENGAGE

Testing, manufacturing, or both.

Engage our cGMP (GLP) analytical laboratory on its own, run manufacturing on its own, or combine both in one program.

ANALYTICAL TESTING 01
In-house cGMP (GLP) analytical testing

Release and stability testing, method development, and batch verification for sterile and oral products. Samples can be submitted directly.

Explore testing →
TPP CDMO 02
Contract development & manufacturing

CMC development through commercial launch: formulation, tech transfer, clinical and commercial cGMP manufacturing, serialized packaging, and distribution.

See full capabilities →
CAPABILITIES

From development to commercial supply.

Formulation and analytical development, technology transfer, clinical and commercial cGMP manufacturing, and packaging with serialization, at one FDA-inspected site in San Diego.

Full CDMO services →
Versatile, multi-form capabilities
01Sterile injectables — liquid & lyophilized
02Tablets — immediate & modified release
03Capsules, incl. liquid-filled hard gelatin
04Oral solutions & suspensions — up to 4,000 L
Specializations: lyophilization, compressed and hard-pressed tablets, liposomes, micro- and nano-particulate suspensions, modified release, controlled substances.
Formulation & analytical developmentPHASE-APPROPRIATE

Physical characterization, excipient compatibility, dosage-form design, solubility assessment, process design and scale-up. Full cGMP QC and analytical labs in-house.

Technology transferIN OR OUT

Structured transfer of products and process knowledge: control strategy, process qualification, and manufacturing readiness on schedule.

Clinical cGMP manufacturing & packagingPH I–III

Clinical supplies for programs at every stage, including matching placebos, with phase-appropriate systems that support trials worldwide.

Commercial manufacturing & packagingSERIALIZED

Scale-up and second-source qualification. Automated packaging lines with serialization and track & trace, controlled-temperature warehousing with DEA vaults, and global distribution.

QUALITY & COMPLIANCE

The inspection record, up front.

Quality systems aligned with FDA, DEA, and international health authority requirements, maintained across three decades of U.S. manufacturing in San Diego.

More about the facility →
Jan 2023 FDA inspection
Most recent inspection passed.
DEA registered
Manufacturer: Schedule IV and V. Analytical lab: Schedule IV and V. On-site vaults.
cGMP QC & analytical labs
Chromatography, spectroscopy, dissolution, particle-size, TOC, DSC/TGA — method development through release testing.
≤ 3A SafeBridge potency
Containment and handling for potent compounds up to Category 3A across the cGMP footprint.
THE FACILITY

Nancy Ridge Drive, San Diego.

24,400 square feet of cGMP development, manufacturing, packaging, and laboratory space, continuing more than 30 years of pharmaceutical manufacturing in San Diego. Our mission today: re-shoring drug manufacturing and supply chains to the United States.

Sterile formulation mixing, automated vial filling, freeze-drying Milling, blending, compression, encapsulation, coating 2,000 L jacketed tanks; batches to 4,000 L Controlled-temperature warehouse with DEA vaults
6828 NANCY RIDGE DRIVE, #100 · SAN DIEGO, CA 92121
See suites & equipment in detail →
Vial filling line
Vial capping line
Facility exterior, Nancy Ridge Drive
LEADERSHIP

Decades of pharmaceutical operating experience.

Meet the team →
Tony Chu
MANAGING DIRECTOR

30+ years of cross-border pharma between the US/EU and Asia: tech transfer, licensing, M&A, and manufacturing strategy.

Michael Derby
DIRECTOR OF FINANCE

25+ years in biopharma. Licensing and BD leadership at Merck, CEO of Castle Creek Pharma, Managing Partner at TardiMed.

START A PROGRAM

Bring your program onshore.

Tell us where your molecule stands. Our development team responds within one business day with an initial assessment and next steps.

Start an inquiry info@tppcdmo.com
858-623-1520 6828 NANCY RIDGE DRIVE, SAN DIEGO CLIENT SPONSORED AUDITS
TPP CDMO

US-based pharmaceutical development and manufacturing in San Diego, California.

6828 NANCY RIDGE DRIVE, #100
SAN DIEGO, CA 92121
SERVICES
CDMO Services Analytical Testing
COMPANY
About & facility Leadership team Contact us
CONTACT
info@tppcdmo.com 858-623-1520 Client sponsored audits welcomed by appointment.
© 2026 TPP Tech. All rights reserved. · Privacy · Terms FDA-inspected · DEA-registered · San Diego, CA
TPP CDMO declares that it is in compliance with both its Compliance Program and Cal. Health & Safety Code §§ 119400-119402.