OPTIMA Pharma GmbH

CDMO

Germany

https://www.optima-packaging.com/en/industries/pharma-and-biotech/aseptic-filling/solutions-for-syringes-cartridges-and-vials-rtu

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Manufacturing & Lab Equipment

Company Overview

About

OPTIMA Pharma GmbH is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in Quality Control, Stability Testing, Method Development

Therapeutic Areas

Rare Disease

Metabolic

Quick Facts

HQ:Germany

Founded:1997

Employees:2,824

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 5 (≤1 µg/m³)

Cytotoxic / ADC Handling

Production Scales

R&D / Pre-clinical

Lab Scale

Pilot Scale

Markets Served

Asia-Pacific

Regulatory Approvals

Drug Approval 3NRCIO

FDA · #APR-SC18YZL0 · 2018-07-01

Drug Approval XVCSTD

FDA · #APR-LE1GG8Q2 · 2022-04-01

Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-7C3CSDYC

Issued: 2020-06-27

Expires: 2025-04-15

ISO 9001:2015

International Organization for Standardization

Cert #: CERT-ET5RMDKQ

Issued: 2020-06-09

Expires: 2025-05-01

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Key facts about OPTIMA Pharma GmbH

OPTIMA Pharma GmbH is headquartered in Germany.
OPTIMA Pharma GmbH was founded in 1997.
OPTIMA Pharma GmbH has 2,824 employees.
OPTIMA Pharma GmbH's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.

Find CDMOs like OPTIMA Pharma GmbH

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

CDMOs in Germany CDMOs in Europe Biologics Drug Substance CDMOs Biologics Drug Product CDMOs Prefilled Syringe CDMOs Sterile Injectable CDMOs OEB 5 (≤1 µg/m³) CDMOs Cytotoxic / ADC Handling CDMOs