Alembic Pharma Gets Four Observations After US FDA Audit at Panelav API Site

MT Newswires Live

2025/06/02

Alembic Pharma (BOM:533573, NSE:APLLTD) received a Form 483 with four observations from the US Food and Drug Administration following a routine inspection at its API-I and API-II facilities in Panelav, Gujarat, according to a Saturday filing on the local bourse.

The inspection, which ran from May 26 to May 31, was unannounced and focused on current good manufacturing practices (cGMP), the company said in a filing.

None of the observations relate to data integrity, and management believes they are addressable. Alembic said it will respond to the regulator within the stipulated timeline.

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Alembic said it will respond to the regulator within the stipulated timeline.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"OTX.SI","symbol_name":"迈怡汇有限公司","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2540756746","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2540756746","pubTimestamp":1748829305,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. 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