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News

CAPLIN STERILES GETS USFDA APPROVAL FOR PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP

Chennai, May 24, 2024: Caplin Steriles Limited (Caplin), a Subsidiary 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) Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% (eye drops), a generic therapeutic equivalent…

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CAPLIN STERILES GETS USFDA APPROVAL FOR OFLOXACIN OPHTHALMIC SOLUTION

Chennai, April 16, 2024: 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) Ofloxacin Ophthalmic Solution USP 0.3% (eye drops), a generic therapeutic equivalent version of…

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CAPLIN STERILES GETS USFDA APPROVAL FOR KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION

Chennai, March 28, 2024: 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) Ketorolac tromethamine Ophthalmic Solution 0.5% (eye drops), a generic therapeutic equivalent version of…

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CAPLIN STERILES GETS USFDA APPROVAL FOR OFLOXACIN OTIC SOLUTION

Chennai, January 08, 2024: 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) Ofloxacin Otic Solution 0.3%, a generic therapeutic equivalent version of (RLD), FLOXIN Otic…

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Caplin Steriles gets USFDA approval for Norepinephrine Bitartrate Injection

Chennai, September 20, 2023: 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) Norepinephrine Bitartrate Injection USP, 4 mg/4 mL (1 mg/mL) Single-Dose Vial, a generic…

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Caplin Steriles receives EIR from US FDA

Caplin Steriles Ltd, a subsidiary of Caplin Point Laboratories Ltd, today announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its injectable and ophthalmic manufacturing unit located near Chennai. The unit underwent an inspection from US FDA during May 22nd ~ May 31st and…

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Caplin Point listed on Forbes Asia’s “200 Best Under a Billion” for 2023

Caplin Point Laboratories Ltd has been recognized in Forbes Asia’s 200 Best Under a Billion list for the year 2023, a compilation that underscores companies’ sustained and robust performance across critical benchmarks. Carefully selected from a substantial pool of more than 20,000 publicly traded companies across the Asia-Pacific region, the chosen 200 enterprises showcase annual…

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CAPLIN STERILES GETS USFDA APPROVAL FOR CISATRACURIUM BESYLATE INJECTION

Chennai, June 12, 2023: 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) Cisatracurium Besylate Injection USP, 10 mg/5 mL (2 mg/mL) and 200 mg/20 mL…

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CAPLIN STERILES GETS USFDA APPROVAL FOR KETOROLAC TROMETHAMINE INJECTION

Chennai, May 12, 2023: 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) Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL Single-dose Vial, a generic…

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