Newgen Biotech (Ningbo) Co., Ltd.

CDMO

China

https://www.newgenbio.com/

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Drug Product

Excipients & Specialty Ingredients

Company Overview

About

Newgen Biotech (Ningbo) Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in Gene Therapy, Cell Therapy, mRNA

Therapeutic Areas

Immunology

Rheumatology

Quick Facts

HQ:China

Founded:2015

Employees:819

Capabilities & Services

Core Capabilities

Peptide Synthesis
Small Molecule API
Formulation Development

Types of Organization

GMP Manufacturing

Quality Systems

Regulatory Support

Dosage Forms

Inhalation

Containment Capabilities

OEB 4 (1-10 µg/m³)

Production Scales

Phase III Clinical Trials

Commercial Scale

Clinical

Markets Served

Global

Regulatory Approvals

Drug Approval XBSWEJ

Health Canada · #APR-QIAB0JSM · 2022-04-01

Drug Approval D90DP6

Health Canada · #APR-5YVEL66G · 2021-02-01

Certifications

EMA GMP Certificate

European Medicines Agency

Cert #: CERT-9YC3KX6H

Issued: 2020-06-07

Expires: 2025-12-22

ISO 9001:2015

International Organization for Standardization

Cert #: CERT-CLDY7W65

Issued: 2020-09-20

Expires: 2025-09-03

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Key facts about Newgen Biotech (Ningbo) Co., Ltd.

Newgen Biotech (Ningbo) Co., Ltd. is headquartered in China.
Newgen Biotech (Ningbo) Co., Ltd. was founded in 2015.
Newgen Biotech (Ningbo) Co., Ltd. has 819 employees.
Newgen Biotech (Ningbo) Co., Ltd.'s capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.

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CDMOs in China CDMOs in Asia Small Molecule API CDMOs Formulation Development CDMOs Inhalation CDMOs OEB 4 (1-10 µg/m³) CDMOs