BioDlink

CDMO

China

https://www.biodlink.com/

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Drug Product

Advanced Modalities

Analytical & Bioanalytical Services

Clinical Trial Supply & Logistics

Regulatory, Tech Transfer & Support Services

Company Overview

About

TOT BIOPHARM is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in Formulation Development, Process Development, Scale-up

Therapeutic Areas

Cardiovascular

Endocrinology

Quick Facts

HQ:China

Founded:2019

Employees:370

Capabilities & Services

Core Capabilities

Sterile Injectable
Sterile Fill/Finish
Fill/Finish (Vials)

Types of Organization

GMP Manufacturing

Quality Systems

Regulatory Support

Dosage Forms

Cartridge / Pen

Containment Capabilities

BSL-2 (Biosafety Level 2)

Production Scales

Phase III Clinical Trials

Commercial Scale

Clinical

Markets Served

Europe

Regulatory Approvals

Drug Approval PIKIAR

FDA · #APR-7XAZCZTP · 2022-01-01

Case Studies

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

Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-KM9JZQS1

Issued: 2020-02-02

Expires: 2025-09-24

ISO 9001:2015

International Organization for Standardization

Cert #: CERT-ZWTZ2Y6W

Issued: 2020-12-27

Expires: 2025-12-09

MHRA GMP

UK Medicines and Healthcare products Regulatory Agency

Cert #: CERT-UFSPZ1UL

Issued: 2020-07-17

Expires: 2025-08-10

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Key facts about BioDlink

BioDlink is headquartered in China.
BioDlink was founded in 2019.
BioDlink has 370 employees.
BioDlink's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).

Find CDMOs like BioDlink

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

CDMOs in China CDMOs in Asia Sterile Injectable CDMOs Fill-Finish CDMOs Fill/Finish (Vials) CDMOs Cartridge / Pen CDMOs BSL-2 (Biosafety Level 2) CDMOs