PrimePharma GmbH
Premium PartnerIreland
Drug Product
Chemistry, Manufacturing and Controls
Qualification/Validation Services
Company Overview
About
PrimePharma GmbH is a leading contract development and manufacturing organization headquartered in Ireland. We specialize in Formulation Development, Clinical Trial Materials, Biologics Manufacturer with state-of-the-art facilities serving clients globally.
Key Expertise
Small Molecule API, Supply Chain Management, Biologics Drug Substance, Microbiology Testing, Method Development & Validation
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:Ireland
Founded:1990
Employees:2
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Technology Platforms
Small Molecule API Manufacturer
Analytical Testing
Dosage Forms
Sterile Injectable
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Pilot Scale
Clinical
Commercial Scale
Batch Sizes
5000L+
1L-10L
100L-1000L
10L-100L
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
PrimePharma GmbH - Headquarters
732 Pharma Drive, Galway, Galway, 95552
45,553 sq ft
Established 2013
Site Capabilities
Small Molecule Drug Product
Antibody-Drug Conjugates (ADC)
Fill/Finish (Syringes)
Lyophilization
Regulatory Approvals
Drug Approval MIS348
FDA · #APR-WXVUI4QT · 2018-08-01
Product Portfolio
Standard Formulation Service
BrochureOur flagship service offering for Respiratory and Ophthalmology applications.
Ointment
Capsule
Tablet
Injectable
Delivery: IV Infusion, Transdermal
Advanced API Service
BrochureOur specialized service offering for Rare Disease and Other applications.
Cream
Capsule
Lyophilized Powder
Delivery: Intramuscular, Inhalation
Standard Formulation Service
BrochureOur flagship service offering for Rare Disease applications.
Lyophilized Powder
Suspension
Capsule
Delivery: Subcutaneous, IV Infusion
Advanced Formulation Service
BrochureOur comprehensive service offering for Cardiovascular applications.
Capsule
Suspension
Delivery: Inhalation, IV Infusion
Case Studies
2 published case studies showcasing past projects, challenges and outcomes.
Infectious Disease Cell Therapy Development Partnership
Lifecycle Management
Cell Therapy
mRNA
Aug 2022 – Jan 2024
397 views
Successful Lifecycle Management manufacturing program for a emerging biotech client.
Challenge
The client required rapid scale-up of their Infectious Disease therapeutic with aggressive timelines and complex analytical requirements.
Solution
We deployed our experienced team and state-of-the-art facilities to develop a robust manufacturing process. Key innovations included process intensification and real-time analytics.
Outcome
The program achieved all milestones on schedule. The product received regulatory approval and is now in commercial production.
Infectious Disease
Metabolic Disease
API Production Cost Reduction Initiative
Phase III
Gene Therapy
Jul 2020 – Sep 2022
177 views
A comprehensive overview of how PrimePharma GmbH successfully delivered this complex pharmaceutical manufacturing project.
Challenge
The client required rapid scale-up while maintaining strict quality standards and regulatory compliance. Time-to-market was critical.
Solution
Our team implemented innovative process optimization techniques, leveraged advanced manufacturing technologies, and established robust quality control systems.
Outcome
Project completed 30% faster than industry average with zero quality deviations. Client achieved regulatory approval on first submission.
Gallery
Immunology
Customer Reviews
4.3
Overall Rating(Based on 21 reviews)
Project Management3.9
Technology Transfer4.8
On-Time Delivery4.8
Communication Responsiveness3.8
Innovation4.2
Company Documents
No documents available.
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