EliteTherapeutics B.V.

CDMO

Italy

https://elitetherapeuticsbv.com

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Drug Product

Advanced Modalities

Analytical & Bioanalytical Services

Manufacturing & Lab Equipment

Company Overview

About

EliteTherapeutics B.V. is a leading contract development and manufacturing organization headquartered in Italy. We specialize in Fill/Finish, Clinical Trial Materials, Cell & Gene Therapy with state-of-the-art facilities serving clients globally.

Key Expertise

Small Molecule API, Antibody-Drug Conjugates (ADC), Microbiology Testing, Formulation Development, Lyophilization

Therapeutic Areas

Infectious Disease

Quick Facts

HQ:Italy

Founded:1992

Employees:181

Capabilities & Services

Core Capabilities

Small Molecule API
Small Molecule Drug Product
Oral Solid Dose

Types of Organization

Contract Research Organization (CRO)

Drug Product Manufacturer (finished dosage, fill-finish, packaging)

Formulation Development

Dosage Forms

Oral Solid Dose

Containment Capabilities

Cytotoxic / ADC Handling

Production Scales

Commercial Scale

Large Scale (Metric Ton+)

Batch Sizes

1L-10L

10L-100L

5000L+

Markets Served

North America

Manufacturing Facilities

1 site worldwide

EliteTherapeutics B.V. - Headquarters

670 Technology Drive, Milan, Milan, 36496

View on Map

454,367 sq ft

Established 1994

Site Capabilities

4 capabilities

Regulatory Support

Antibody-Drug Conjugates (ADC)

Microbiology Testing

Viral Vectors

Regulatory Approvals

Drug Approval QC9OX0

EMA · #APR-TUKHXU0H · 2019-05-01

Drug Approval 1ZL6DE

Health Canada · #APR-ZU7AK1K4 · 2021-08-01

Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-2E57J5OC

Issued: 2020-04-13

Expires: 2025-01-02

ISO 13485:2016

International Organization for Standardization

Cert #: CERT-SVF9PN8A

Issued: 2020-10-05

Expires: 2025-11-14

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Key facts about EliteTherapeutics B.V.

EliteTherapeutics B.V. is headquartered in Italy.
EliteTherapeutics B.V. was founded in 1992.
EliteTherapeutics B.V. has 181 employees.
EliteTherapeutics B.V. has one manufacturing site listed on CDMO Hub, in Milan, Italy.
EliteTherapeutics B.V.'s capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.

Find CDMOs like EliteTherapeutics B.V.

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

CDMOs in Italy CDMOs in Europe Small Molecule API CDMOs Small Molecule Drug Product CDMOs Oral Solid Dose CDMOs Oral Solid Dose CDMOs Cytotoxic / ADC Handling CDMOs

Key facts about EliteTherapeutics B.V.

EliteTherapeutics B.V. is headquartered in Italy.

EliteTherapeutics B.V. was founded in 1992.

EliteTherapeutics B.V. has 181 employees.

EliteTherapeutics B.V. has one manufacturing site listed on CDMO Hub, in Milan, Italy.

EliteTherapeutics B.V.'s capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.