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Gerresheimer at CPhI South East Asia: The production of Duma and Triveni containers will be extended by a plant in ChinaDüsseldorf/Bangkok, )
"Due to the high demand in Asia, we have decided to build another plant in China in addition to the locations in Europe, India and America. From this base we can supply many of our customers in the Asia region and strongly support even better those customers, who want to access the regulated US pharmaceutical market with their drugs packed into our products,“ says Jari Tevajarvi, Vice President Asia Plastic Packaging.
The plant in Changzhou
The product portfolio will comprise pharmaceutical containers with closures and dropper bottles with accessories. The containers will be available with filling volumes from 30 ml to 3,800 ml and will include the leading Duma Twist-off container models as well as Triveni containers with an induction seal. All containers are provided with various types of closure options (for example, to protect the original contents, child-resistant and/or user-friendly for the elderly), and are available with different forms of desiccants (integrated/mounted) and adsorbents. The plant is certified according to ISO-standards ISO 9001 (quality), ISO 14001 (environmental management), ISO 15378 (quality management for manufacturers of primary packaging materials for medicinal products) and ISO 18001 (occupational health and safety management system). Production is carried out in a modern Class 7 classified cleanroom (10.000) and will begin in the second half of 2019.
White products – CFDA-registered
All products comply fully with the requirements of the European Pharmacopoeia and the US Food and Drug Administration (FDA), with a Drug Master File (DMF) as standard. Since the start of the year, the white products manufactured at the Triveni plant in Kundli have been registered with the China Food and Drug Administration (CFDA). The Drug Master File (DMF) numbers have been published on the CDE (Center of Drug Evaluation) website. The next step is a technical review by the CDE as soon as a customer has submitted the drug file together with the letter of authorization (LoA) for the DMF. Several Chinese customers have now started their registration process. As soon as their files have passed the technical review, the DMF will be activated and the information marked with an “A” on the platform.
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