By MEGGLE Excipients
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MEGGLE fully embraces Chinese Pharmacopoeia
Wasserburg, Germany: – Pharmaceutical lactose specialist MEGGLE Excipients & Technology (MEGGLE) marks China’s Year of the Ox 2021 by taking a further step to show its commitment to the Chinese pharmaceutical market.
MEGGLE has officially extended its product specifications to explicitly highlight compliance of the excipient with the Chinese Pharmacopoeia (ChP).
Expanded testing regime
The move required MEGGLE to institute new tests into its quality system, which were necessary to comply with ChP.
The change gives Chinese and multinational companies easier access to MEGGLE excipients and corresponding documentation, providing significantly improved user convenience from a regulatory perspective.
MEGGLE has so far been able to place more than 30 of its excipients on the National Medical Products Administration (NMPA), formerly known as CFDA, Center for Drug Evaluation (CDE) platform.
The CDE is responsible for technical review of all drug applications and listing is a prerequisite to the use of MEGGLE excipients in pharmaceutical drug manufacturing in China.
More than ten of the MEGGLE excipients have been awarded “A” Status on the NMPA on this platform.
Furthermore, MEGGLE ‘s China Representative Office in Shanghai is capable of issuing appropriate Chinese language letters of authorization (LOAs) that are also required for incorporating MEGGLE products into drug registration and manufacturing in China.
MEGGLE has been supporting the Chinese pharmaceutical market with its products and services for almost two decades. With the contribution of its representative office in China, headed by Dr. Yi Kang, local customers have been quickly and comprehensively served. Either technical or quality related queries have been followed up with full commitment, respecting local Chinese requirements.
About MEGGLE Wasserburg
Bavarian-based MEGGLE is one of the world’s experts in co-processing and powder technology. From its roots as a dairy operation in the late 1880’s, MEGGLE has become one of the world’s leading manufacturers of pharmaceutical lactose, supplying the pharma market segment with a broad-based and unique lactose product portfolio.
MEGGLE Excipients & Technology has harnessed outstanding product quality and intelligent innovation to become a global leader in the manufacture of lactose-based excipients, focusing on products for direct tableting and dry powder inhalation.
A multidisciplinary team of committed and highly qualified people allows MEGGLE clients to benefit from pioneering experience and innovative drive in industrial milk and whey processing. The company constantly strives to develop high-tech, functional products for solid dosage forms and DPI applications, where they can deliver maximum performance.
The company has introduced several pioneering products, notably Tablettose®, the world’s first agglomerated lactose for direct tableting, Cellactose® 80, a pioneering co-processed excipient based on cellulose-lactose for outstanding compression and flow properties and RetaLac®, the first direct compression co-processed excipient using a hypromellose-lactose base for sustained release formulations.
To learn more, visit: https://www.meggle-pharma.com/en/home.html
Click on NMPA Center for Drug Evaluation for further information on CDE listing in China.