Chennai, Sep 3rd, 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) Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL (0.2 mg/mL) and 40 mg/200…
Chennai, May 14, 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) Haloperidol Decanoate Injection, 50mg/mL and 100mg/mL Single Dose Vials; 500mg/5mL (100mg/mL) Multiple-Dose Vials, a…
Chennai, April 23, 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) Phytonadione Injectable Emulsion USP, 10 mg/mL, Single Dose Vial, a generic therapeutic equivalent version…
Chennai, Feb 26th, 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) Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution (Eye drops), 0.2%/0.5% in 5mL, 10mL and…
Chennai, Feb 05, 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) Procainamide Hydrochloride Injection USP, 1g/10mL and 1g/2mL Vials, a generic therapeutic equivalent version of…
Chennai, Jan 17, 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) Levetiracetam in Sodium Chloride Injection, 500mg/100mL, 1000mg/100mL and 1500mg/100mL infusion bags (Large Volume Parenteral),…
Chennai, January 06, 2025: Caplin Point Laboratories Ltd. (“Caplin Point” or the “Company”) (BSE: 524742 | NSE: CAPLIPOINT), announced today that it has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the recent inspection conducted at Caplin Steriles’ injectable and ophthalmic manufacturing facility located at Gummidipoondi. The unannounced USFDA…
Chennai, Dec 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) Difluprednate Ophthalmic Emulsion, 0.05% (Eye drops), a generic therapeutic equivalent version of the Reference…
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…
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…
