{"id":25928,"date":"2025-10-23T09:18:00","date_gmt":"2025-10-23T09:18:00","guid":{"rendered":"https:\/\/www.caplinpoint.net\/?p=25928"},"modified":"2026-02-17T05:44:18","modified_gmt":"2026-02-17T05:44:18","slug":"caplin-steriles-gets-usfda-approval-for-nicardipine-hydrochloride-in-0-9-sodium-chloride-injection-infusion-bags","status":"publish","type":"post","link":"https:\/\/www.caplinpoint.net\/index.php\/2025\/10\/23\/caplin-steriles-gets-usfda-approval-for-nicardipine-hydrochloride-in-0-9-sodium-chloride-injection-infusion-bags\/","title":{"rendered":"CAPLIN STERILES GETS USFDA APPROVAL FOR NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION, INFUSION BAGS"},"content":{"rendered":"\n<p><strong>Chennai, Oct 23rd , 2025: Caplin Steriles Limited (Caplin),<\/strong> a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection, 20 mg\/200 mL (0.1 mg\/mL) and 40 mg\/200 mL (0.2 mg\/mL) Single-dose Infusion Bags, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) from Hikma International Pharmaceuticals LLC.<\/p>\n\n\n\n<p>Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. According to IQVIATM (IMS Health), Nicardipine Hydrochloride in Sodium Chloride Injection had US sales of approximately $68 million for the 12-month period ending August 2025.<\/p>\n\n\n\n<p>Caplin had also acquired the following four approved ANDA products in the recent months from third parties:<\/p>\n\n\n\n<ul><li>Icatibant Acetate Injection<\/li><li>Paricalcitol Injection<\/li><li>Gatifloxacin Ophthlamic Solution<\/li><li>Ketamine Hydrochloride Injection<\/li><\/ul>\n\n\n\n<p>According to IQVIATM (IMS Health), the collective market size for the above products in the US is approximately $121 million for the 12-month period ending August 2025. These products will be introduced into US and other markets in 2026.<\/p>\n\n\n\n<div class=\"wp-block-file\"><a target=\"_blank\" href=\"https:\/\/www.caplinpoint.net\/wp-content\/uploads\/2025\/04\/Press_Release__sd-1.pdf\" class=\"wp-block-file__button\" rel=\"noopener\">Source<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Chennai, Oct 23rd , 2025: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection, 20 mg\/200 mL (0.1 mg\/mL)&#8230; <\/p>\n","protected":false},"author":1,"featured_media":1229,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":[],"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/posts\/25928"}],"collection":[{"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/comments?post=25928"}],"version-history":[{"count":2,"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/posts\/25928\/revisions"}],"predecessor-version":[{"id":25943,"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/posts\/25928\/revisions\/25943"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/media\/1229"}],"wp:attachment":[{"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/media?parent=25928"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/categories?post=25928"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.caplinpoint.net\/index.php\/wp-json\/wp\/v2\/tags?post=25928"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}