ALEMBIC PHARMACEUTICALS LTD. - 533573 - Announcement under Regulation 30 (LODR)-Analyst / Investor Meet - Intimation
The exchange is hereby informed that the Company will hold Post Results Conference Call on 11th November, 2022 as per the enclosed details. ALEMBIC PHARMACEUTICALS LTD. - 533573 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
With reference to the captioned subject, this is to inform the exchange that the Company has received US Food & Drug Administration (USFDA) Final Approval for Glycopyrrolate Injection USP, 0.2 mg/1 mL and 0.4 mg/2 mL (0.2 mg/mL) Single-dose Vials and 1 mg/5 mL (0.2 mg/mL) and 4 mg/20 mL (0.2 mg/mL) Multiple-dose Vials. Please find enclosed herewith our press release. ALEMBIC PHARMACEUTICALS LTD. - 533573 - Board Meeting Intimation for Board Meeting To Consider Unaudited Financial Results For The Quarter And Half Year Ended 30Th September, 2022
ALEMBIC PHARMACEUTICALS LTD.has informed BSE that the meeting of the Board of Directors of the Company is scheduled on 11/11/2022 ,inter alia, to consider and approve Unaudited Financial Results for the quarter and half year ended 30th September, 2022 Alembic Pharma gets USFDA nod for generic injection to treat cancer
Paclitaxel injection is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary ALEMBIC PHARMACEUTICALS LTD. - 533573 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
With reference to the captioned subject, this is to inform the exchange that the Company has received US Food & Drug Administration (USFDA) Final Approval for Paclitaxel Injection USP, 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL) Multiple-Dose Vials. Please find enclosed herewith our press release. ALEMBIC PHARMACEUTICALS LTD. - 533573 - Successful Completion Of USFDA Inspection At Alembic Pharmaceuticals' Bioequivalence Facility At Vadodara
We would like to inform the exchange that the Company has successfully completed the United States Food and Drug Administration (USFDA) inspection for its Bioequivalence Facility located at Vadodara without any observations. The inspection was conducted from 17th October, 2022 to 21st October, 2022. ALEMBIC PHARMACEUTICALS LTD. - 533573 - Compliances-Reg. 39 (3) - Details of Loss of Certificate / Duplicate Certificate
With reference to the captioned subject, please find enclosed herewith the intimation dated 20th October, 2022 received from Link lntime India Private Limited, Registrar and Share Transfer Agent, regarding receipt of the request(s)/application(s) from the registered shareholder(s) of the Company for issue of Duplicate Share Certificate(s).
USFDA issues four observations to Alembic Pharma's Panelav plant
Alembic Pharmaceuticals Ltd on Tuesday said the US health regulator has issued a Form 483 with four procedural observations after inspection of its oncology injectable formulation facility at Panelav in Gujarat. As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The USFDA had conducted an inspection at the facility located at Panelav from October 4, 2022, to October 14, 2022, Alembic Pharmaceuticals said in a regulatory filing. "The USFDA issued a Form 483 with 4 procedural observations. None of the observations is related to data integrity, and management believes that they are addressable," it added. The company further said it is preparing the response to the observations, which will be submitted to the USFDA within the stipulated period. ALEMBIC PHARMACEUTICALS LTD. - 533573 - USFDA Inspection At Alembic Pharmaceuticals' Oncology Injectable Formulation Facility At Panelav
We would like to inform that the United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals' Oncology Injectable Formulation Facility located at Panelav from 4th October, 2022 to 14th October, 2022. The USFDA issued a Form 483 with 4 procedural observations. None of the observations are related to data integrity and management believes that they are addressable. The Company is preparing the response to the observations, which will be submitted to the USFDA within stipulated period. The Company is committed to maintain the highest quality standards and compliance at all times. ALEMBIC PHARMACEUTICALS LTD. - 533573 - Compliances-Certificate under Reg. 74 (5) of SEBI (DP) Regulations, 2018
With reference to the captioned matter, please find enclosed herewith a Certificate under Regulation 74(5) of SEBI (Depositories and Participants) Regulations, 2018 for the quarter ended 30th September, 2022, received from M/s. Link Intime India Private Limited, Registrar and Share Transfer Agent of our Company. We request you to kindly take the same on record.