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 Brimonidine Tartrate Ophthalmic Solution,0.15%. 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 intimations dated 29th March, 2023 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 - Alembic Pharmaceuticals Limited Passes ANVISA (Brazil) GMP Audit For Its API-III Facility At Karakhadi
We would like to inform the exchange that the Company has successfully completed the Brazilian Health Regulatory Agency (ANVISA) GMP audit at API-III Facilty at Karakhadi without any observations for its 56 APIs. The inspection was conducted from 20th March, 2023 to 24th March, 2023. ALEMBIC PHARMACEUTICALS LTD. - 533573 - USFDA Inspection At Alembic Pharmaceuticals' Injectable Facility (F-3) At Karakhadi
We would like to inform that the United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals' Injectable and Ophthalmic Facility (F-3) located at Karkhadi from 16th March, 2023 to 24th March, 2023. The USFDA issued a Form 483 with 2 minor 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 intimations dated 13th March, 2023 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 - Successful Completion Of USFDA Inspection At Alembic Pharmaceuticals' Derma Facility At Karakhadi
We would like to inform the exchange that the Company has successfully completed the United States Food and Drug Administration (USFDA) inspection for its Derma Facility located at Karakhadi without any observations. The inspection was conducted from 6th March, 2023 to 10th March, 2023.
Alembic Pharma gets USFDA nod to market generic antidepressant drug
Alembic Pharmaceuticals on Thursday said it has received an approval from the US health regulator to market a generic antidepressant medication in the American market. The company has received an approval from the US Food & Drug Administration to market Brexpiprazole tablets in strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, the drug firm said in a statement. The company's product is therapeutically equivalent to Otsuka Pharmaceutical Co's reference listed drug product Rexulti tablets, it added. Brexpiprazole tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for the treatment of schizophrenia. According to IQVIA data, Brexpiprazole tablets in strenghts of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of USD 1.6 billion for 12 months ended December 2022. The US market is the world's largest for pharmaceutical products. In 2021-22 fiscal, India's total pharma exports to global... 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) Tentative Approval for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. Please find enclosed herewith our press release. 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 Prazosin Hydrochloride Capsules USP, 1 mg, 2 mg, and 5 mg. 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 intimations dated 7th March, 2023 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).