Drug Product
Company Overview
About
Gualadispensing Pharma is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Neurology
Quick Facts
HQ:Italy
Founded:1999
Employees:3,074
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
North America
Regulatory Approvals
Drug Approval RWMS50
FDA · #APR-PK1CAVO4 · 2020-11-01
Drug Approval TL4CZR
PMDA · #APR-AK7FDAKR · 2021-06-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-BSPB37F6
Issued: 2020-06-28
Expires: 2025-10-08
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-660HKWU8
Issued: 2020-10-03
Expires: 2025-07-10
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Key facts about Gualadispensing Pharma
- Gualadispensing Pharma is headquartered in Italy.
- Gualadispensing Pharma was founded in 1999.
- Gualadispensing Pharma has 3,074 employees.
- Gualadispensing Pharma's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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