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Hi, Single DMF with two different specifications is not possible. ------------------------------ [Deepa] [Dasgupta, RAC] [Director] Director Hyderabad [India] ------------------------------

Yes Sabrina, Completeness assessment (CA) of DMF is not applicable for NDA.CA is linked with GDUFA and hence having DMF assessed prior to ANDA filing is mandatory. ------------------------------ [Deepa] [Dasgupta, RAC] [Director] Director Hyderabad [India] ------------------------------

Hello holly, An authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under Indian rules, shall make an application for grant of import licence for medical device to the Central Licensing Authority through an identified online portal of ...

Hello Holly, Different rules are applicablle, if anyone intends to manufacture device in India or get it imported and distributed in india. Also there have been major device rules change in 2017. Let me know specific query, I may suggest you accordingly. ------------------------------ [Deepa] ...

Yes, 2 lots of API can be used for  3 DP batches manufacturing. However more than 2 would be a worse case scenario as per ICH guideline. ------------------------------ Deepa Dasgupta RAC Director Hyderabad India ------------------------------