USFDA inspection: Caplin Steriles gets 4 observations for Gummidipoondi site
Chennai: Caplin Steriles Limited has announced that the United States Food and Drug Administration (USFDA) has issued four observations at the end of the GMP and PAI inspection at the company's Sterile Injectable site at Gummidipoondi.
The inspection was held between May 22nd to 31st.
"We would like to inform you that the United States Food and Drug Administration (USFDA) had completed its GMP and PAI inspection of Caplin Steriles Limited’s (a subsidiary of Caplin Point Laboratories Limited) Sterile Injectable site at Gummidipoondi between May 22nd to 31st," the company stated in a BSE filing.
"These observations are procedural in nature and the corrective and preventive actions for these observations will be presented to the US FDA within the stipulated period. The observations made were not repeat observations or related to data integrity," Caplin Steriles further stated.
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Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a niche sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP and ANVISA. Caplin Steriles Limited, has developed and filed 30 ANDAs in USA on its own and with partners, with 21 approvals so far. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products, that it intends to file over the next 4 years.
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