2018
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Question
[CLICK ON ANY CHOICE TO KNOW THE RIGHT ANSWER]
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Bivalirudin
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Meropenem
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Vaborbactam
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INFUGEM
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Detailed explanation-1: -The USFDA approved only 635 ANDAs in 2021, as compared to 761 in the previous year. In the year 2017, the USFDA approved 844 ANDAs, and the number slowly started to diminish thereafter. The R&D based Indian pharma majors secured 210 ANDA approvals from USFDA which worked out to 33 per cent of total approvals.
Detailed explanation-2: -The main consumer watchdog in this system is FDA’s Center for Drug Evaluation and Research (CDER).
Detailed explanation-3: -According to US FDA observations, that facilities at Aurobindo Pharma’s Unit 7 does not follow written procedures for production or process controls. Its batch production and control records do not include complete information and written stability testing program is not followed at the facility.