Standard Chem. & Pharm. Co., Ltd.

Premium Partner

CDMO

Taiwan

https://www.scp.com.tw/

Drug Product

Company Overview

About

Standard Chem. & Pharm. Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in Quality Control, Stability Testing, Method Development

Therapeutic Areas

Neurology

Quick Facts

HQ:Taiwan

Founded:1991

Employees:316

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

Commercial Scale

Large Scale (Metric Ton+)

Markets Served

Europe

Regulatory Approvals

Drug Approval YBOXGO

Health Canada · #APR-IWC97FBJ · 2019-08-01

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Drug Approval 3JLGE0

EMA · #APR-QA7UHYP6 · 2020-05-01

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Case Studies

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

Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-5393XT4V

Issued: 2020-05-15

Expires: 2025-08-25

Download

EMA GMP Certificate

European Medicines Agency

Cert #: CERT-O9OVHGWC

Issued: 2020-06-23

Expires: 2025-12-17

Download

MHRA GMP

UK Medicines and Healthcare products Regulatory Agency

Cert #: CERT-OD06KJ4H

Issued: 2020-01-24

Expires: 2025-08-06

Download

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