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Completion of inspection by ANVISA-Brazil at the facility of Caplin Steriles Limited

This is to inform you that ANVISA- Brazil conducted an inspection of Caplin Steriles’ injectable and ophthalmic manufacturing facility located at Gummidipoondi. The inspection was conducted between August 12th and 16th, 2024 and concluded with zero observations. Chairman Mr.C.C.Paarthipan added “It is indeed gratifying to have two back to back audits with Zero observations. We remain…

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Completion of Unannounced US FDA Inspection at the facility of Caplin Steriles Limited

This is to inform you that the United States Food and Drug Administration (US FDA) conducted an unannounced inspection of Caplin Steriles’ injectable and ophthalmic manufacturing facility located at Gummidipoondi. The inspection was conducted between August 5th and 9th, 2024 and concluded with zero observations. This outcome underscores the company’s strong commitment to maintaining the…

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CAPLIN STERILES GETS USFDA APPROVAL FOR TIMOLOL MALEATE OPHTHALMIC SOLUTION USP

Chennai, Aug 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) Timolol Maleate Ophthalmic Solution USP, 0.5% (Eye drops), a generic therapeutic equivalent version of…

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CAPLIN STERILES GETS USFDA APPROVAL FOR EPHEDRINE SULFATE INJECTION USP

Chennai, JULY 19, 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) Ephedrine Sulfate injection USP, 50 mg/mL Single Dose vial, a generic therapeutic equivalent version…

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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 version…

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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 (RLD),…

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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 (RLD),…

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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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