TEDOR Pharma Services

TEDOR Pharma Services

TS
Company Profile

TEDOR Pharma Services

Cumberland, United States of America

Formulation & Process Development Analytical Services Clinical Trial Supply Services Solid Dose Commercial Manufacturing About Us Who We Are Our Facility Our Team
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About

About TEDOR Pharma Services Tedor Pharma Services is a reliable, US-based CDMO with over 20 years of experience in solid dosage forms, headquartered in Cumberland, RI on the Rhode Island- Massachusetts border an hour drive from Boston. Our expert team provides guidance and flexible, end-to-end outsourcing solutions for small and dry powder large molecule drug product development. We offer manufacturing from clinical phase I through large-scale commercial production for worldwide clients, utilizing decades of industry knowledge and quality manufacturing experience to help bring your product to market. As a committed CDMO, Tedor Pharma Services has invested in our facility’s infrastructure and expert staff to ensure customer success, facilitating easy tech transfers with our robust QMS and excellent regulatory track record. We partner with companies of all sizes, from those with diverse commercial portfolios to virtual companies navigating regulatory filings (IND, NDA, ANDA) or post-ANDA acquisition. Tedor delivers high-quality, cost-competitive GMP manufacturing services, is DEA licensed for controlled substances (CI-CV), and specializes in small batch and complex product formulation. Our comprehensive solutions encompass: Formulation & Process Development: Collaborative and transparent approach to address complex delivery profiles, including precise release mechanisms, API combinations, and challenging APIs. We support products from early clinical phases to commercial scale, tackling tough formulation and manufacturing challenges for diverse platforms like tablets, capsules, high/low potency, modified/extended release, powders, granulations, beads, bi-layer tablets, extrusions, slugs, liquids, creams, lotions, suppositories, hollow core, multi-fill capsules, enteric-coated, and effervescent formulations. Analytical Services: Rigorous capabilities essential for drug product development, reproducibility, and quality assurance from pre-formulation to commercialization. Our robust services support product development, process optimization, regulatory filing, and quality assurance, including material characterization, stability assays, thermal analysis, particle size, dissolution studies, solution stability, filter/flush evaluation, limits of detection/quantitation, linearity/range, specificity (including forced degradation), and product release testing. Clinical Trial Supply Services: Deep commitment to supporting each phase of clinical development with high flexibility for shifting timelines and extensive experience in storing and shipping investigational drug products. We provide comprehensive support for regulatory submissions, utilizing GMP and GCP approaches to safeguard IDP supply with tailored tooling and manufacturing to match product characteristics. Commercial Manufacturing: Full product lifecycle support for solid dose manufacturing, from development to clinical and commercial scales, with straightforward tech transfer processes. We handle diverse solid dose complexities, including tablets, capsules, single & multi-layer tableting, immediate and modified-release formulations, extended-release, DEA schedules I-V, high-potency, poorly soluble/variable APIs, multi-API products, pelletized products, various coatings, abuse deterrent, dry large molecule, encapsulation, powder biologics, and orphan drug small-batch manufacturing. We offer primary and secondary commercial source manufacturing options for security of supply.

Address
400 Highland Corporate Drive, Cumberland RI 02864, United States of America