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Hi, We have submitted ANDA to Agency in December 2019. GDUFA Goal date for this ANDA is October 2020. Review of this ANDA is going on & we received several DRL from the Agency & submitted our response. It seems we are now at the end stage of the review of ANDA. However, in one of the DRL, FDA stated ...

Dear Members, We are developing a Fixed-Dose Combination (FDC) drug which includes two API. As per literature data, the Maximum daily dose (MDD) of one API is 300 mg and for other API Maximum daily dose is 3 mg. As per ICH Q3B, Identification threshold for the API with MDD of 3 mg  is 0.5%  (1 ...

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 ...

Dear Members, We have developed & validated a method of a Product as per Current USP monograph which is USP-41. However, as per recent USP Pharmacopoeial forum, this method(Specifically Impurity Method) is going to be revised in the USP 43(4) & accordingly we have validated the impurity method again ...

Dear All, Thanks a lot for all your valuable suggestions regarding setting up of impurity limit. ------------------------------ Thanks & Best regards Rajib Kumar Baishnab Manager, Regulatory Affairs The ACME Laboratories Ltd. Dhamrai, Dhaka-1350, Bangladesh Ph: +8801990-407587 Email: ...