Dear members,
According to the guidance, "Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules", Agency recommends manufacturing tablets and capsules that have a similar shape or have a shape that has been found to be easier to swallow compared with the shape of the RLD.
Based on the recommendation given in the above guidance, we have developed the same shape(Oval, Tiltab) of Generic Tablet. However, the shape of the RLD tablet is TILTAB & have registered trademarks.
According to Orange Book, there is no patent & exclusivity available for this RLD.
Can we manufacture the same shape of Tablet as RLD based on the above guidance & Is there any issue if we conduct the Bioequivalence study of this product with the same shape as RLD.
Thanks & Best regards
Rajib Kumar Baishnab
Senior Manager, Regulatory Affairs
The ACME Laboratories Ltd.
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Thanks & Best regards
Rajib Kumar Baishnab
Manager, Regulatory Affairs
The ACME Laboratories Ltd.
Dhamrai, Dhaka-1350, Bangladesh
Ph: +8801990-407587
Email:
rbaishnab.qo@acmeglobal.com------------------------------