Company Info

Societal™ CDMO

CDMO

Tagline

Bringing Science to Society™

Overview

Societal CDMO (NASDAQ: SCTL) is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO provides therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging, and logistics services to the global pharmaceutical market. This includes extensive experience in handling DEA controlled substances and high potency compounds.

Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.

Company Services

Services/CapabilitiesCDMO

+ Biologic Manufacturing Capacities

Scale

+ Development Services

Analytical Development & Validation
Preformulation/Formulation
Process Development & Validation
Raw Material Testing
Release & QA/QC Testing
Scale Up/Tech Transfer
Stability Testing

+ Drug Product Manufacturing

Clinical Trial Material Manufacturing
Controlled Substance Drug Products
Dedicated Suites
Encapsulation/Capsules Manufacturing (Hard, Soft)
Solid Dosage Manufacturing (Tablet, Powder)
Vials Aseptic Fill Finish Manufacturing
Clinical and Commercial Scale
High Potency Compounds (OEL < 1µg/m3)
Oral Liquid

+ OSD Product Type

Bi-layered Tablets
Coated Compressed Tablets - Direct compression
Coated Compressed Tablets - Wet Granulation
Enteric Coated Tablets
Film Coated Tablets
Manufactured Tablets using Solvents
Pellet in Capsule
Powder in Capsule
Sugar coated tabets
Multiparticulates, mini-tabs, granules/sprinkles

+ Packaging

Blisters
Bottles
Carton Packaging
Clinical Trials Packaging
Labeling
Non Sterile Liquid Packaging
Serialization / Aggregation
Stick packs/Sachets/Unit Dose
Storage/Warehousing
Strip (Alu/Alu, PVC, PVDC)
Tertiary Packaging
Vials/Ampoules Packaging

Regulatory/CertificationsCDMO

Focus Area/Product TypeCDMO

Therapeutic CategoriesCDMO

Contributors

Anna Dormady

Elliott Franco, Ph.D.

Prakash Pandian

Alex Dunlap

Ania VanDyke

Jared A. Baird, Ph.D.

Sally Langa

Jeff Tremain

Yadira Salamander

Brian P. Haney, Ph.D.

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