source： author： Publication time：2019-05-14 browse：1368
Tai Heng submitted the DMF of an undisclosed API product to US FDA in behalf of one of our Chinese client, and received FDA’s DMF Acknowledgement Letter on May 7, 2019. This indicates the submitted DMF passed FDA administrative review.
During less than 9 months, Tai Heng has completed the production of three process validation batches, release tests of all raw materials and final product, 6 months stability tests of final product, and DMF dossier compilation, including eCTD conversion. DMF was submitted on April 11, 2019.
Tai Heng is currently working with our client to ensure the timely FDA review, and subsequent FDA inspection. As part of contact development strategy, Tai Heng will continue to provide our resource and experience to support our client's US and global strategy, and bring products to market.