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 Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg. Please find enclosed herewith our press release. ALEMBIC PHARMACEUTICALS LTD. - 533573 - Closure of Trading Window
With reference to the captioned matter, this is to inform the exchange that in terms of the Company's Code of Conduct for Regulating, Monitoring and Reporting of Trading by Designated Persons and their Immediate Relatives framed pursuant to SEBI (Prohibition of Insider Trading) Regulations, 2015, the trading window for dealing in securities of the Company will remain closed from 1st January, 2023 till 48 hours after the declaration of the unaudited financial results for the quarter and nine months period ended 31st December, 2022. The date of the Board Meeting for inter alia considering the unaudited financial results for the quarter and nine months period ended 31st December, 2022 will be intimated in due course.
Alembic Pharma gets USFDA nod for generic drug to treat breast cancer
Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for its generic Fulvestrant injection used in treatment of breast cancer. The approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA), Fulvestrant injection of strength 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, the company said in a statement. The approved injection is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, of AstraZeneca Pharmaceuticals LP, it added. Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of breast cancer, the company said. For 12 months ended September 2022, Fulvestrant injection, 250 mg/5 mL, had an estimated market size of USD 71 million, the company said citing IQVIA data. 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 Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-Dose Prefilled Syringe. Please find enclosed herewith our press release. 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 23rd December, 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). 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 PAS (Prior Approval Supplement) approval from US Food & Drug Administration (USFDA) for Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg. Please find enclosed herewith our press release. ALEMBIC PHARMACEUTICALS LTD. - 533573 - USFDA Inspection At Alembic Pharmaceuticals' Solid Oral Formulation Facility (F-4) At Jarod
We would like to inform that the United States Food and Drug Administration (USFDA) has conducted PAI (Pre-Approval Inspection) at Alembic Pharmaceuticals' Solid Oral Formulation Facility (F-4) located at Jarod. The USFDA issued a Form 483 with 5 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-Reg. 39 (3) - Details of Loss of Certificate / Duplicate Certificate
With reference to the captioned subject, please find enclosed herewith the intimation dated 12th December, 2022 received from Link lntime India Private Limited, Registrar and Share Transfer Agent, regarding receipt of the request/application from the legal heir(s) of the registered shareholder(s) of the Company for issue of Duplicate Share Certificate(s) for the purpose of claiming the shares from the Investor Education and Protection Fund (IEPF). ALEMBIC PHARMACEUTICALS LTD. - 533573 - Alembic Pharmaceuticals Limited Receives Establishment Inspection Report (EIR) For Its Oncology Injectable Formulation Facility At Panelav
This is to inform the exchange that the Company has received Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for the inspection carried out by them at our Oncology Injectable Formulation Facility at Panelav during the period from 4th October, 2022 to 14th October, 2022. This was pre-approval inspection to cover our Oncology Injectable drug products for which ANDAs were filed with USFDA. The Company had also started receiving ANDA approval manufactured at this facility. We request you to kindly take the same on record. 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 Desonide Cream, 0.05%.