UPM PHARMACEUTICALS, INC
501 5th Street
Bristol, TN 37620
T: +1 973-879-2735
E: info@upm-inc.com
W: www.upm-inc.com

UPM Pharmaceuticals is a contract development and manufacturing organization (CDMO) with 30+ years of US based experience in development to later-stage clinical and commercial manufacturing of oral solid and semi-solid dosage forms.

Beyond our expertise and technology, UPM is a contract manufacturing organization that has a passion for propelling our customers’ journeys from early-stage development to the market, even when the journey doesn’t begin with us. As a large-scale CDMO, technology transfer and scale-up are our specialties; we welcome the opportunity to sit down with you to create a pharma solution by understanding the evolution of your project, your clinical and commercial goals, and how we can work together to get your product across the finish line.

Whether your product is oral-solid or semi-solid dose, establishing the appropriate analytical framework and formulation design is vital to ensuring optimal production at clinical and commercial scale. UPM’s R&D and formulation experts have advanced several complex compounds from concept to commercialization, applying multidisciplinary expertise to develop the best processing conditions and formulation solutions for each unique product. UPM also offers a safe, and compliant handling of DEA-controlled substances and potential home for potent compounds.

FACILITY

Operating out of a 475,000-square-foot, large-scale cGMP and FDA-guided manufacturing facility with DEA licensing in Bristol, Tennessee, UPM combines the robust track record of a pharmaceutical supplier with the agility of an independent, family-owned US-based CDMO. For our customers, this translates to exceptional quality and reliability, and a level of personalized service not often seen in a larger CDMO companies in the US.

DEVELOPMENT SERVICES

Formulation development for tablets and capsules:
– Immediate Release
– Modified Release
– Oral Disintegrating Tablets
Modified releases via:
– Matrix Tablets
– Delayed or sustained Release Tablet
– Coating
– Particle Coating for Capsule Fill
– Coated Pellets for Compressed tablets
Combined technologies
Development by QBD principles, with formal DOE
Clinical Batch Manufacturing, for IND, Phase I, II, III Studies; Manufacturing of Generic
Bio-Studies
Registration batch manufacturing
Content Uniformity Evaluation
Biologics Process Development
Potency
Dissolution Testing
Stability Assessment
In-vitro Dissolution Profile Evaluation
Powder Flow Determination
Topical Formulation Development
Compressibility Evaluation
Disintegration Testing
Friability Testing
Tap density Testing
Particle size Testing
Micro Testing

MANUFACTURING SERVICES

Blending
Coating
Compression
Drying (Spray & Oven)
Encapsulation
Filtration
Granulation
Heating
Shearing
Tableting

PHARMA TECHNOLOGY TRANSFER & SCALE-UP CAPABILITIES

Technology transfer from bench scale to pilot scale to commercial scale manufacturing
Site transfer of existing development or commercial products and processes
Process development, for all tablet and capsule unit operations
Risk Gap Analysis
Transfer and Qualification of Analytical Assays
Project Management
Technical and Analytical Support
Development and Implementation of Analytical and Manufacturing Processes
Technical Writing
Validation Strategy Development
Stability Studies
Regulatory Filing
Scale-Up Support

PACKAGING/SERIALIZATION CAPABILITIES

3 Solid Dose Bottle Lines for Tablets and Capsules
50–100 Bottles per Minute
Nitrogen Blanketing
Automated Semi-solid Tube and Jar Line for Creams and Ointments
Vibratory Line
Low-humidity Solutions
Thick-wall Bottles, Desiccants, Oxygen Absorbers, and Nitrogen Purging
Offline serialization strategy
Ability to work with all serialization codes
Preprinted labels, electronically verified
DSCSA compliant

CONTROLLED SUBSTANCES MANUFACTURING CAPABILITIES

Approvals for Schedule II–V controlled substances and listed chemicals
Formulation, process and method development/validation
Stability and degradation testing
Offsite Warehousing in 8,300 square feet of DEA Approved vault space
Onsite Warehousing in 7,200 square feet of DEA Approved vault space