CDMO Solutions

Our pharmaceutical CDMO delivers end-to-end oral solid dosage (OSD) and Dry Powder Inhalation (DPI) drug product services, from pre-formulation to cGMP released drug product. DEA Schedule I to V licensed. FDA inspected. Nine approved and six active commercial products manufactured for US and international markets.

9

Products approved from this site

6

Currently in active commercial manufacturing, US and international markets

5

Successful FDA inspections in the past 8 years

12

Successful regulatory audits in the past 8 years

DEA

Schedule I to V analytical and manufacturing licensed

Highlighted Capabilities

FOR EARLY-PHASE PROGRAMS

First-in-Human: Quick to Clinic

Deliver cGMP drug product to the clinic faster.
Designed for early-phase programs that need speed without compromising quality or regulatory compliance.

Encapsulate drug substance directly into a capsule to create drug product
Xcelodose® Precision Powder Micro-dosing System
cGMP compliant for clinical trial supply

PROVEN COMMERCIAL TRACK RECORD

9 Approved Products. 6 on the Market Today.

Nine products have been approved for commercial for commercial manufacturing at this site. Eight of these products were developed at Tampa, FL and only one was transferred. Six products with active commercial manufacturing for US and international markets.

9 products approved from this site
6 currently in active commercial manufacturing
Present in US and international markets
Includes bottle and blister commercial packaging
Includes capsule, tablet and DPI products

Highly skilled and dedicated team. Proven expertise from pre-clinical to commercial for oral solid and inhaled drug products. Our development experts work hand in hand with our manufacturing team to ensure consistent, reliable commercial supply.

Challenge	How we solve it
Need to get to clinic fast	First-in-human quick-to-clinic option: cGMP drug product from drug substance with minimal formulation development.
Too many vendors across the lifecycle	One site: development, clinical manufacturing, QC, packaging, storage, regulatory.
DEA-scheduled compound complexity	DEA Schedule I to V analytical and manufacturing licenses in place.
Highly potent compound handling	Dedicated HPAPI containment for oral solid dosage and DPI manufacturing.
Regulatory submission risk	5 FDA inspections. 12 non-US market audits.
Current CDMO has no proven path to commercial	9 approvals. 6 products on market today. From this site.

CDMO Capabilities

Full-lifecycle oral solid dosage and DPI drug product services, with format-specific development and manufacturing capabilities under a shared quality and regulatory framework.

Oral Solid Dosage (OSD)

Product Development DEA Schedule I to V – Analytical License

PRE-FORMULATION

API characterization
Excipient compatibility
Feasibility studies

FORMULATION DEVELOPMENT

Immediate release tablets and capsules
Modified release tablets and capsules
Micro-dosing and low-dose formulations

ANALYTICAL DEVELOPMENT

Method development and validation

cGMP Manufacturing | DEA Schedule I to V – Manufacturing License

DOSAGE FORMS

Immediate release tablets and capsules
Modified release tablets and capsules

PRECISION DOSING

Micro-dosing and low-dosing PIC
Xcelodose® Precision Powder System
Harro Hofliger
MG2

SPECIAL CAPABILITIES

HPAPI high-containment manufacturing
Clinical and commercial scale

Dry Powder Inhalation (DPI)

Product Development DEA Schedule I to V – Analytical License

PRE-FORMULATION

API characterization for inhalation
Particle engineering
Feasibility studies

FORMULATION DEVELOPMENT

DPI formulation development
Inhalation performance optimization

ANALYTICAL DEVELOPMENT

Method development and validation
Inhalation and DPI analytical services

cGMP Manufacturing | DEA Schedule I to V – Manufacturing License

DPI MANUFACTURING

Zephyr® DPI capsule manufacturing
Clinical and commercial scale

PRECISION DOSING

Micro-dosing and low-dosing PIC
Xcelodose® Precision Powder System
Harro Hofliger

SPECIAL CAPABILITIES

HPAPI high-containment manufacturing
Gerteis Roller Compactor
Bi-layer tablets
Pancoating
Fette Tableting Equipment
Tablet in Capsule technology
Low Humidity

Shared services across oral solid dosage and DPI

The following capabilities serve both product formats under the same quality system, team, and DEA licensing framework.

cGMP Packaging | DEA Schedule I to V – Manufacturing License

PRIMARY PACKAGING

Manual and automated bottling
Blistering: thermoform and coldform

SECONDARY PACKAGING

Secondary packaging
Kitting and serialization

Quality Control Testing and Stability | DEA Schedule I to V – Analytical License

ANALYTICAL QC

QC release testing
In-process testing
Raw materials laboratory

STABILITY

Multiple ICH stability storage conditions
Long-term, accelerated, and stress testing

MICROBIOLOGY

Environmental monitoring (EM)
Raw material testing
Product microbiology

Warehouse Storage and Logistics | cGMP

RAW MATERIALS

GMP dispensing of raw materials for MFG and PKG

PRODUCT STORAGE

Clinical product storage

Regulatory Affairs | Global submissions support

DOCUMENTATION

Prepare regulatory documents for filing
IND, NDA, ANDA, and MAA support

SUBMISSIONS

Support for regulatory submissions
Post-approval regulatory support

STRATEGY

Guidance on regulatory strategy
Inspection readiness

Need to get to clinic fast?

Ask us about our first-in-human quick-to-clinic option for early-phase oral solid dosage and DPI programs. Contact us here.

Drug Product Lifecycle Coverage

Engage our CDMO solutions team at any stage in the lifecycle of a product, with full continuity of quality assurance, project management, and regulatory compliance throughout.

Familiarization R&D

Process development
Analytical development
Scale-up
Pilot testing

Engineering cGMP

Process optimization
Product characterization
Scale-up
Specifications
Impurity profiling

cGMP Manufacture

Process characterization
Process validation
Clinical and commercial scale-up

Commercial Manufacturing

Technology transfer
Post-market scale-up and optimization
Regulatory Affairs support

Therapeutic Areas

Our CDMO solutions support oral solid dosage and DPI programs across:

Oncology and HPAPIs
Respiratory and inhalation
CNS
Metabolic and chronic diseases
Oral peptides
Rare diseases

Regulatory Credentials

5 successful FDA inspections and 12 regulatory audits in the past 8 years, across five major health authorities. Quality assurance systems built for global regulatory compliance from day one.

FDA

United States

MHRA

United Kingdom

ANVISA

Brazil

Ministry of Health

Turkey

Ministry of Health

Russia

Part of the global pharmaceutical solutions network

Need early-stage formulation development? Explore Innovaform® Accelerator, our European center for custom capsule design and DPI formulation development, with a structured pathway for cGMP transfer to our Tampa CDMO site.