Simtra BioPharma Solutions is a global contract development and manufacturing organization (CDMO) focused exclusively on sterile injectables. With more than 65 years of manufacturing expertise, Simtra combines deep technical know-how, global reach and a strong quality record to help pharma and biotech innovators bring complex medicines to patients. Simtra operates facilities in Bloomington, Indiana, and Halle/Westfalen, Germany.

Company (Headquarters):

United States

Types of Drugs Manufactured:

Small Molecule;Biologics

CDMO Services:

Drug Product/FDF;Regulatory Services;Analytical Development;Process & Forumulation Development

Therapeutic Area:

Cardiovascular;Central Nervous System;Dermatology;Endocrine and Hormonal;Gastrointestinal and Metabolism;Immunology;Infectious Disease;Musculoskeletal System;Oncology;Ophthalmology;Rare and Genetic Disorders;Respiratory;Pain Symptoms

CDMO Number of Facilities:

3

High Potent Products capabilities:

OEB 4-5 Highly Potent APIs (HPAPIs)

Facilities Location:

Europe;North America

Regulatory Approvals for facilities:

USA – FDA;Europe – EMA or constituent countries;UK – MHRA;GMP;ISO 9001;Canada – Health Canada;Japan – MHLW;China – NMPA;Brazil – ANVISA;Australia – TGA;South Korea – MFDS;India – CDSCO;ISO 14001

Manufacturing Technologies:

Lyophilized amps/vials;Pre-Filled Syringes (PFS);Sterile Vials