Stringent Quality Control

  • Complete Traceability for Raw Material Enables Strict Control over All Parts of the Manufacturing Operation

    01 The Production Site for Heparin API

    Guaranteed traceability for every batch of raw material

    02 Raw Material Processing Line

    Scaled productionRegular inspectionsRaw material produced with consistent processes delivered to Shenzhen

    03 Casing Factory

    Control of the process begins at the casing factoryCollection of the mucous membrane of pig’s small intestine

    04 Meat Processing Plant

    Scaled productionsOnsite inspectorsOnly harvest material from healthy pigs

  • High Product Quality Secured by a Comprehensive Quality Management System

    Techdow has established a comprehensive and advanced quality control system that covers the entire product lifecycle going from research and development and technology transfer to commercial manufacturing to product phase-outs. Based on 1,400+ validated/confirmed technologies and 1,200+ management docs and operating manuals, this system secures the sustained production of safe and effective medicines for patients.

  • Techdow’s Enoxaparin Sodium Injection Leads the Market with its Proven Product Quality

    Techdow is the first EU-certified Chinese manufacturer of enoxaparin sodium injections. Its enoxaparin sodium injection is the first enoxaparin sodium biosimilar injection approved by the EMA in the EU and the first generic enoxaparin sodium injection with all of its SKUs passed the Bioavailability Equivalence Evaluation of the Quality and Efficacy of Biosimilar in China.

  • Techdow's production lines are compliant with the highest standards adopted by some of the world's biggest markets

    Techdow's production lines are compliant with the highest GMP standards adopted by some of the major markets around the world. Since inception, these production lines have obtained a series of GMP certifications by regulators of China, the United States, European Union, and Brazil, etc.

By adhering to the highest quality standards, Techdow will remain
prepared for future GMP certifications by regulators from around the world.

2004

Shenzhen Techdow Pharmaceutical Co., Ltd. established

2006

Passed GMP certification by China

2007

Passed GMP certification by Brazil

2008

Passed GMP certification by Australia

2010

Passed GMP certification by China

2011

Passed GMP certification by China and Brazil

2012

Passed GMP certification by the U.S. and Colombia

2013

Passed GMP certifications by the EU

2014

Passed GMP certification by Brazil

2015

Passed GMP certification by China, the EU and the U.S.

2016

Passed GMP certification by China, the EU, Colombia and Korea

2017

Passed GMP certification by Brazil

2018

Passed GMP certification by the EU and the U.S.

2019

Passed GMP certification by the EU, the U.S. and Peru

2020

Passed GMP certification by China

2021

Passed GMP certification by the EU and Kazakhstan

2022

Passed GMP certification by the EU

2023

Passed the GMP compliance inspection by Kazakhstan, Turkey and China

2024

Passed the GMP compliance inspection by China

Further Beyond

Stay prepared for more GMP inspections by applying the stringent quality control

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