USFDA scrutiny delays generic drug approvals for major Indian pharma firms

Quick Summary:

The number of abbreviated new drug applications (ANDAs) approved fell to its lowest level in eight quarters, according to a report by the Times of India.

The USFDA is also reportedly piloting a Quality Management Maturity (QMM) programme, which aims to improve the supply chain and reduce drug shortages through quality management practices.

Cipla recently reported a 7 per cent increase in revenue to Rs 6,694 crore and an 18 per cent rise in net profit to Rs 1,178 crore for Q1 FY25, supported by strong performance in both India and the US markets.

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Article Details

Category: BusinessFinance

Markets: India

Topics: US pharma market ANDA approvals Indian pharma companies Drug manufacturing India Pharmaceutical industry ANDA Generic drug approvals USFDA scrutiny Quality management

Source Website Secure: Yes (HTTPS)

News Sentiment: Neutral

Fact Checked: Legitimate

Article Type: News Report

Published On: 2024-07-30 @ 11:06:40 (7 hours ago)

News Timezone: GMT +5:00

News Source URL: business-standard.com

Language: English

Article Length: 491 words

Reading Time: 3 minutes read

Sentences: 21 lines

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Copyright Owner: © Business Standard

News ID: 21849349

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