S-LAB Sp. z o.o.

CDMO

Poland

https://s-lab.pl/

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Drug Product

Company Overview

About

S-LAB Sp. z o.o. is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines

Therapeutic Areas

Neurology

Quick Facts

HQ:Poland

Founded:2005

Employees:2,678

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

BSL-2 (Biosafety Level 2)

Production Scales

Pilot Scale

Clinical

Commercial Scale

Markets Served

Europe

Regulatory Approvals

Drug Approval PCJMDX

Health Canada · #APR-IDT1DPTO · 2018-05-01

Drug Approval UOHKA9

PMDA · #APR-JAT1SSR2 · 2020-11-01

Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-P6Y2LZ0T

Issued: 2020-03-23

Expires: 2025-04-26

EMA GMP Certificate

European Medicines Agency

Cert #: CERT-RII3S6IF

Issued: 2020-11-10

Expires: 2025-12-02

ISO 9001:2015

International Organization for Standardization

Cert #: CERT-ZMF01FXB

Issued: 2020-08-07

Expires: 2025-07-19

WHO GMP

World Health Organization

Cert #: CERT-ZKYULSDP

Issued: 2020-10-13

Expires: 2025-10-19

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Key facts about S-LAB Sp. z o.o.

S-LAB Sp. z o.o. is headquartered in Poland.
S-LAB Sp. z o.o. was founded in 2005.
S-LAB Sp. z o.o. has 2,678 employees.
S-LAB Sp. z o.o.'s capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.

Find CDMOs like S-LAB Sp. z o.o.

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

Fill-Finish CDMOs Topical / Transdermal CDMOs BSL-2 (Biosafety Level 2) CDMOs