Aptuit LLC

Premium Partner

CDMO

Italy

https://www.aptuit.com/

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Drug Product

Contract Research Organization

Company Overview

About

Aptuit LLC is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in Formulation Development, Process Development, Scale-up

Therapeutic Areas

Rare Disease

Metabolic

Quick Facts

HQ:Italy

Founded:2005

Employees:2,548

Capabilities & Services

Core Capabilities

Biologics Drug Substance
Biologics Drug Product
Biologics Manufacturing

Types of Organization

GMP Manufacturing

Quality Systems

Regulatory Support

Dosage Forms

Prefilled Syringe

Sterile Injectable

Containment Capabilities

OEB 4 (1-10 µg/m³)

Production Scales

Pilot Scale

Phase I Clinical Trials

Clinical

Markets Served

Global

Manufacturing Facilities

4 sites worldwide

Aptuit (Scientific Operations), LLC

1701 W Vine St, Harrisonville, Missouri, 64701

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Aptuit (Oxford) Ltd

Building 111, Innovation Drive, Milton Park, Milton, Abingdon, Oxfordshire OX, 14 4RZ

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Site Capabilities

2 capabilities

ANALYSIS

API MANUFACTURE

Aptuit Ltd

Heriot Watt University Research Park, Edinburgh

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Aptuit (Verona) Srl

Via Alexander Fleming 4, Verona, 37135

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Site Capabilities

1 capability

ANALYSIS

International Regulatory

EU GMP Certificates

Regulatory Bodies

EMA/EudraGMDP

Regulatory Approvals

Drug Approval AWHQUE

EMA · #APR-ZMPZKBB9 · 2018-07-01

Case Studies

0 published case studies showcasing past projects, challenges and outcomes.

Certifications

ISO 9001:2015

International Organization for Standardization

Cert #: CERT-NOZG3XUA

Issued: 2020-06-12

Expires: 2025-08-10

ISO 13485:2016

International Organization for Standardization

Cert #: CERT-H7A1JJYP

Issued: 2020-12-27

Expires: 2025-08-04

Health Canada GMP

Health Canada

Cert #: CERT-UU1725S0

Issued: 2020-08-05

Expires: 2025-09-02

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Key facts about Aptuit LLC

Aptuit LLC is headquartered in Italy.
Aptuit LLC was founded in 2005.
Aptuit LLC has 2,548 employees.
Aptuit LLC has 4 manufacturing sites listed on CDMO Hub, in Harrisonville, United States, Abingdon, United Kingdom, Edinburgh, United Kingdom and Verona, Italy.
Aptuit LLC's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.

Find CDMOs like Aptuit LLC

Directory pages this company appears in, each with the full list of matching manufacturers.

CDMOs in Italy CDMOs in Europe Biologics Drug Substance CDMOs Biologics Drug Product CDMOs Prefilled Syringe CDMOs Sterile Injectable CDMOs OEB 4 (1-10 µg/m³) CDMOs

Key facts about Aptuit LLC

Aptuit LLC is headquartered in Italy.

Aptuit LLC was founded in 2005.

Aptuit LLC has 2,548 employees.

Aptuit LLC has 4 manufacturing sites listed on CDMO Hub, in Harrisonville, United States, Abingdon, United Kingdom, Edinburgh, United Kingdom and Verona, Italy.

Aptuit LLC's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.