Shilpa Medicare Limited: bortezomib

However, to comply with MAPP 5019.1 (official as of January 28, 2022), we suggest you include a gross content test with upper and lower acceptance criteria in the drug product specification.

Following surveillance inspection of the oe manufacturing facility listed in this application, FDA conveyed deficiencies to the representative of the facility.

April 8, 2022, which were not reviewed for this action.

Drug, and Cosmetic Act for Pemetrexed Injection, for intravenous use.

Your response to the May 30, 2021, information request related to deliverable volume (dose) data was not submitted.

Federal Food, Drug, and Cosmetic Act for Bortezomib injection.

Shilpa Medicare Limited's approach of using the 7 is insufficient to address the safety concerns of the high osmolality of the proposed drug product.

(a) Conduct clinical studies to demonstrate the comparable bioavailability/bioequivalence and safety of your drug product.

(5) During a recent inspection of the manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.

Satisfactory resolution of deficiencies is required before this application may be approved.