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Quarterly results:Alembic reports revenue for Q1 FY23 Rs. 1262 Cr.

 

Financial Highlights

India Branded Business Ex of Covid related products grew by impressive 20%.

International Generics Business de-grew by 3% to Rs. 549 Cr.

 

Vadodara, August 4th, 2022

Alembic Pharmaceuticals Limited reported its consolidated financial results for the quarter ending 30th June, 2022

Mr. Shaunak Amin, Managing Director, Alembic Pharmaceuticals Limited said “India Branded Business continues to deliver robust numbers in Q1. India Business will witness market outperforming growth across most of the products and therapy areas in current year.”

 

Mr. Pranav Amin, Managing Director, Alembic Pharmaceuticals Limited said “It was tough quarter with significant price erosion in the US market, we also charged off a non-recurring expense of Rs. 115 Cr.”

 

Profit before tax for the quarter is Rs. 47 Cr. before charging off the above non-recurring expense.

 

Operational Highlights

International Generics

7 ANDA filed in Q1 FY23. Cumulative ANDA filings at 237.

8 ANDA approvals received in Q1 FY23 Cumulative ANDA approvals 167.

US Generics at Rs. 367 Cr. in the Q1 FY23.

Ex-US International Formulations at Rs.182 Cr. in the Q1 FY23.

 

India Branded Business

India Branded Business at Rs. 480 Cr. in the Q1 FY23.

Ex of Covid related products, growth of India Branded Business is 20%.

 

API

API business at Rs. 233 Cr. in the Q1 FY23.

1 DMFs were filed in the quarter.

 

 

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the US FDA. Alembic is one of the leaders in branded generics in India. Alembic’s brands, marketed through a marketing team of over 5500+ are well recognized by doctors and patients.

Information about the company can be found at www.alembicpharmaceuticals.com; (reuters:ALEM.NS) (bloomberg:ALPM) (nse:APLLTD) (bse:533573)

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Alembic Pharmaceuticals announces its wholly owned subsidiary, Aleor Dermaceuticals Limited receives USFDA Final Approval for Lidocaine and Prilocaine Cream USP, 2.5%/2.5%.

Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly owned
subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US
Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for
Lidocaine and Prilocaine Cream USP, 2.5%/2.5%. The approved ANDA is therapeutically
equivalent to the reference listed drug product (RLD) EMLA Cream, 2.5%/2.5%, of Teva
Branded Pharmaceutical Products R&D, Inc. Lidocaine 2.5% and Prilocaine 2.5% cream (a
eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on normal intact skin for local analgesia and genital mucous membranes for
superficial minor surgery and as pretreatment for infiltration anesthesia. Lidocaine 2.5% and
Prilocaine 2.5% cream is not recommended in any clinical situation when penetration or
migration beyond the tympanic membrane into the middle ear is possible because of the
ototoxic effects observed in animal studies
Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US$29
million for twelve months ending Dec. 2021 according to IQVIA.

Alembic has received a cumulative total of 163 ANDA approvals (140 final approvals and 23
tentative approvals) from USFDA.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited, a vertically integrated research and development
pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered
in India, Alembic is a publicly listed company that manufactures and markets generic
pharmaceutical products all over the world. Alembic’s state of the art research and
manufacturing facilities are approved by regulatory authorities of many developed countries
including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic’s
brands, marketed through a marketing team of over 5000 are well recognized by doctors and
patients.
Information about Alembic can be found at https://www.alembicpharmaceuticals.com/;

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Alembic Pharmaceuticals recieves USFDA approval for Opthalmic Solution.

Drug firm Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, used to treat certain types of glaucoma and other causes of high pressure inside the eye.

The approved product is therapeutically equivalent to the reference listed drug product (RLD) Cosopt Ophthalmic Solution, 2 per cent and 0.5 per cent, of Akorn Operating Company LLC.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2 per cent and 0.5 per cent, Alembic Pharmaceuticals said in a regulatory filing.

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.

Quoting IQVIA data, Alembic Pharma said Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2 per cent and 0.5 per cent has an estimated market size of USD 80 million for twelve months ending December 2020.

Alembic now has a total of 143 ANDA approvals (125 final approvals and 18 tentative approvals) from