Ashland opens Nanjing excipient plant citing growing local demand in light of new quality regulations

By Gareth Macdonald contact

- Last updated on GMT

iStock/eyegelb
iStock/eyegelb

Related tags: China, Pharmacology, People's republic of china

Ashland has opened a pharmaceutical excipients plant in Nanjing, China in a bid to capture growing local demand for modern formulation technologies.

The facility will make excipients for local drug producers and international pharmaceutical firms with operations in China according to Ashland.

Chinese authorities have been working to improve the quality of drug excipients over the past few years​, partly as a result of a series of high profile scandals.

In April 2012 it was discovered that a number of excipient manufacturers in​ China had been using gelatine derived from leather waste – rather than food-grade gelatine – in capsule–based drug products.

Quality clampdown

As a result​ Chinese authorities announced plans to shake up how excipient production is regulated. Part of this involved​ making drug manufacturers responsible for ensuring the quality of the excipients used in their products.

In 2015​ authorities significantly expanded the number of excipient monographs included in the Chinese Pharmacopoeia - from 130 to 381- in a bid to improve standards.

This regulatory pressure has increased demand for excipients that meet quality standards according to Ashland CEO, William A. Wulfsohn.

Opening a world-class excipient facility in Nanjing is a testament to our willingness to partner with industry in China and to support the integrity and usability of pharmaceuticals produced in a country that is rapidly modernizing its healthcare infrastructure​.”

Quality

The Nanjng plant – Ashland’s first in China - will produce cellulose and PVP polymer-based excipients all of which will be sold with a Registered Pharmaceutical Excipient Certificate, which is required by the Chinese Food & Drug Administration.

It will also house a quality control laboratory kitted out with Thermal Fourier transform infrared spectrometers, Agilent liquid chromatography systems, and PE ICP optical emission spectrometers selected in compliance with Chinese testing requirements.

According to Ashland, production at the new facility will be carried out in collaboration with formulation scientists at the firm’s recently expanded pharmaceutical technical centre in the capital Shanghai.

Western interest

Ashland is not the only western producer to have responded to Chinese demand for excipients.

In September​ Ashland's PVP market rival BASF began producing PVP at a facility in Shanghai. 

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