ALEMBIC PHARMA LTD

Alembic Pharmaceuticals Limited manufactures and markets generic pharmaceutical products all over the world. The company's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the US FDA. The company is one of the leaders in branded generics in India. Alembic Pharmaceuticals Limited was incorporated on June 16, 2010 as a wholly owned subsidiary of Alembic Limited. The company is engaged in pharmaceuticals business. As per the Scheme of Arrangement, the 'Pharmaceutical Undertaking' of Alembic Limited got demerged and transferred to the Company with effect from April 1, 2010. In April 2011, the company ceased to be a subsidiary of Alembic Ltd consequent to the allotment of 13,35,15,914 equity shares of Rs 2 each to the shareholders of Alembic Ltd as per the scheme of arrangement. The shareholding of Alembic Ltd in the company reduced from 100% to 29.18%. Thus, the company became an associate of Alembic Ltd. In September 2011, the equity shares of the company were listed on the Bombay Stock Exchange and National Stock Exchange. During 2012, Alembic and Breckenridge Announced Paragraph IV ANDA Litigation with Pfizer on Desvenlafaxine (Pristiq). The company enters into a product development and license agreement with Accu-Break Pharmaceuticals, Inc, USA. During 2013, the company got USFDA approval for its NDA - Desvenlafaxine Base Extended Release Tablets and also entered into an out-licensing agreement with Ranbaxy Pharmaceuticals Inc (Ranbaxy) to market its product in USA. During 2014, the company announces joint venture with Adwiya Mami SARL Algeria through its wholly owned Subsidiary - Alembic Global Holding S.A.'. During 2015, the company's associate signs exclusive agreement with Novartis. During the year, the company launched Aripiprazole on Day-1. Also during the year, the company transitioned to own marketing in the US. In 2016, the company formed 60:40 joint venture with Orbicular viz. Aleor Dermaceuitical Limited for developing Dermatology Products for international markets. In July 2017, Alembic Pharmaceuticals inaugurated a state of the art anti-cancer manufacturing facility at Panelav, Halol, Gujarat. The plant has an initial manufacturing capacity of 60 million tablets/capsules and approximate 20 million vials of liquid injectable and lyophilized concentrates. Alembic will commence exporting oncology products from the new plant to US, Middle East, North Africa, Australia and South Africa. On 1 November 2017, Alembic Pharmaceuticals announced that through its 100% owned subsidiary, Alembic Pharmaceuticals Inc., it has completed acquisition of West Caldwell, New Jersey, USA based generic drug developer Orit Laboratories LLC along with real estate, owned by Okner Realty LLC. Orit has seven approved ANDAs and four ANDAs pending approval. With a state-of-the-art 8,600 square feet R&D and pilot manufacturing facility, Orit is focused on developing and filing oral solid and liquid products. Apart from existing ANDAs, Orit adds complementary skill sets in soft gelatin based oral solids and oral liquids to Alembic with a team of eight highly experienced scientists. On 21 March 2018, Alembic Pharmaceuticals announced that the United States Food and Drug Administration (US FDA) conducted an inspection at the company's formulation facility located at Panelav, Gujarat from 12 March to 20 March 2018. This was a scheduled inspection and at the end of the inspection, the US FDA issued a Form 483 with 3 observations. None of the observations are related to data integrity or repetitive in nature. The company is preparing the response to the observations, which will be submitted to the US FDA shortly. On 24 April 2018, Alembic Pharmaceuticals announced that the United States Food and Drug Administration (US FDA) conducted an inspection at Alembic Pharmaceuticals API Facility located at Panelav from 16 April 2018 to 23 April 2018. This was a scheduled inspection and at the end of the inspection, there were zero 483s. In 2019, the Company launched 9 new products in the US. In 2021, Rhizen's out-licenced, novel molecule 'Umbralicib (UKONIQ)' was launched by TG Therapeutics USA. During the year 2021-22, the Company acquired the balance 40% stake held by the joint venture partner in Aleor Dermaceuticals Limited (Aleor) and pursuant to said acquisition, Aleor became a wholly owned subsidiary of the Company. The wholly owned subsidiary, Aleor Dermaceuticals Limited got amalgamated with the Company, making the Scheme of Arrangement effective from 29th August, 2022. During FY23, the Company filed 20 ANDAs and received approvals for 22 ANDAs taking the total filed ANDAs to 245 as on March 31, 2023. At Panelav, Alembic set up dedicated blocks (F2) for manufacturing oncology products which was approved by the US FDA in 2022. The Company launched various new products, especially in the gynecology and anti-diabetic spaces; it launched 33 new SKUs in FY23, of which 66% were in specialty therapies. It established a subsidiary in Chile to gain a strong foothold in the large and growing Latin American markets. It opened a scientific office in the UAE to capitalise on the opportunities emerging from the GCC nations. Alembic launched 27 new products, including 18 oncology, derma and ophthalmic product in FY24. The Company launched products in speciality and animal health space in FY24. It formed a subsidiary in the UAE by setting up a scientific office during the year. The US Generic business scaled volumes to counter price erosion via strengthening the supply chain in FY 25. It has launched 16 new products, of which 9 OSD, 2 Injectable, 2 Ophthalmic, 3 Dermatology.