AstaTech (Chengdu) BioPharmaceutical Corp.

China

https://en.astatech.com.cn/

Drug Product

Analytical & Bioanalytical Services

Company Overview

About

AstaTech (Chengdu) BioPharmaceutical Corp. is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in Quality Control, Stability Testing, Method Development

Therapeutic Areas

Oncology

Hematology

Quick Facts

HQ:China

Founded:2009

Employees:404

Capabilities & Services

Core Capabilities

Oral Solid Dose
Solid Dose Manufacturing
Formulation Development

Technology Platforms

GMP Manufacturing

Quality Systems

Regulatory Support

Dosage Forms

Lyophilized (Freeze-Dried)

Sterile Injectable

Containment Capabilities

OEB 5 (≤1 µg/m³)

Cytotoxic / ADC Handling

Production Scales

Phase III Clinical Trials

Commercial Scale

Clinical

Markets Served

Asia-Pacific

Manufacturing Facilities

1 site worldwide

AstaTech (Chengdu) BioPharmaceutical Corp. - China Facility

China

View on Map

Site Capabilities

Quality Control

Stability Testing

Method Development

Regulatory Approvals

Drug Approval AUFJ31

Health Canada · #APR-CUI0M1IY · 2021-07-01

View

Drug Approval 8ESNY5

PMDA · #APR-U97WK79T · 2022-03-01

View

Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-ZMANYXX5

Issued: 2020-12-21

Expires: 2025-09-06

Download

WHO GMP

World Health Organization

Cert #: CERT-O078LOWX

Issued: 2020-05-23

Expires: 2025-11-10

Download

MHRA GMP

UK Medicines and Healthcare products Regulatory Agency

Cert #: CERT-Z26DIXDY

Issued: 2020-01-12

Expires: 2025-10-18

Download

Health Canada GMP

Health Canada

Cert #: CERT-43UCSYZL

Issued: 2020-10-21

Expires: 2025-03-27

Download

Customer Reviews

3.9

Overall Rating

Project Management4.7

Technology Transfer3.8

On-Time Delivery3.6

Communication Responsiveness3.8

Innovation3.7

Company Documents

No documents available.

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AstaTech (Chengdu) BioPharmaceutical Corp.

China

https://en.astatech.com.cn/

Drug Product

Analytical & Bioanalytical Services

Company Overview

About

AstaTech (Chengdu) BioPharmaceutical Corp. is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in Quality Control, Stability Testing, Method Development

Therapeutic Areas

Oncology

Hematology

Quick Facts

HQ:China

Founded:2009

Employees:404

Capabilities & Services

Core Capabilities

Oral Solid Dose
Solid Dose Manufacturing
Formulation Development

Technology Platforms

GMP Manufacturing

Quality Systems

Regulatory Support

Dosage Forms

Lyophilized (Freeze-Dried)

Sterile Injectable

Containment Capabilities

OEB 5 (≤1 µg/m³)

Cytotoxic / ADC Handling

Production Scales

Phase III Clinical Trials

Commercial Scale

Clinical

Markets Served

Asia-Pacific

Manufacturing Facilities

1 site worldwide

AstaTech (Chengdu) BioPharmaceutical Corp. - China Facility

China

View on Map

Site Capabilities

Quality Control

Stability Testing

Method Development

Regulatory Approvals

Drug Approval AUFJ31

Health Canada · #APR-CUI0M1IY · 2021-07-01

View

Drug Approval 8ESNY5

PMDA · #APR-U97WK79T · 2022-03-01

View

Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-ZMANYXX5

Issued: 2020-12-21

Expires: 2025-09-06

Download

WHO GMP

World Health Organization

Cert #: CERT-O078LOWX

Issued: 2020-05-23

Expires: 2025-11-10

Download

MHRA GMP

UK Medicines and Healthcare products Regulatory Agency

Cert #: CERT-Z26DIXDY

Issued: 2020-01-12

Expires: 2025-10-18

Download

Health Canada GMP

Health Canada

Cert #: CERT-43UCSYZL

Issued: 2020-10-21

Expires: 2025-03-27

Download

Customer Reviews

3.9

Overall Rating

Project Management4.7

Technology Transfer3.8

On-Time Delivery3.6

Communication Responsiveness3.8

Innovation3.7

Company Documents

No documents available.

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Send Inquiry

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