Alembic Pharmaceuticals Limited (Alembic Pharma) is an Indian multinational pharmaceutical company headquartered in Vadodara, Gujarat. The company manufactures and markets pharmaceutical products, including active pharmaceutical ingredients (APIs) and formulations, and has a presence in the macrolide anti-infective drug segment.
It produces formulations for therapeutic areas such as cardiology, dermatology, diabetes, ophthalmology, and infectious diseases for domestic and international markets. Alembic operates manufacturing facilities in Gujarat (Panelav and Karakhadi), Sikkim, and Pithampur, and maintains research and development centres in India and the United States.
History
Alembic Chemical Works Company Ltd. was established in 1907, beginning operations in Vadodara with the manufacturing of tinctures and alcohol. The company later diversified into cough syrups, vitamins, tonics, and sulphur drugs. In the 1960s, Alembic began producing penicillin, with its plant inaugurated in 1961 by then Prime Minister Lal Bahadur Shastri. The company initiated bulk production of vitamin B12 and introduced erythromycin manufacturing in 1971, launching the Althrocin brand, which became one of India's top-selling erythromycin brands by 1997. In 1999, the company name was changed from Alembic Chemical Works Company Ltd. to Alembic Limited.[4]
In 2007, Alembic acquired the non-oncology formulation business of Dabur Pharma Ltd for ₹159 crore.[5]
In 2010, Alembic Pharmaceuticals Limited was demerged from Alembic Ltd., following the allotment of 133,515,914 equity shares of ₹2 each to Alembic Ltd. shareholders, reducing Alembic Ltd.’s stake to 29.18%. The company’s shares were listed on the Bombay Stock Exchange and National Stock Exchange on 20 September 2011, following its demerger.[4]
In 2014, Alembic Pharmaceuticals formed a joint venture with Adwiya Mami SARL to enter Algeria.[6] In 2017, the company acquired Orit Laboratories LLC. USA.[4] In 2019, Alembic entered the Chinese market through a joint venture.[7]
In 2022, the company acquired 100% stake in Aleor Dermaceuticals Ltd. and merged it with Alembic Pharmaceuticals Limited.[8][9] In 2025, its U.S. subsidiary acquired Utility Therapeutics Ltd for US$12 million, which produced the urinary tract infection drug Pivya (pivmecillinam 185 mg).[10]
Regulatory approvals
Between 2024 and 2025, Alembic Pharmaceuticals obtained multiple final and tentative approvals from the United States Food and Drug Administration (US FDA) for generic medicines. In December 2024, the company received tentative approval for Olopatadine Hydrochloride Ophthalmic Solution 0.7%, a generic version of Pataday Once Daily Relief.[11] This was followed by final approval for Rivaroxaban tablets in strengths of 2.5 mg, 10 mg, 15 mg, and 20 mg, therapeutically equivalent to Xarelto in May 2025, and for Amlodipine and Atorvastatin tablets in multiple strengths, equivalent to Caduet.[12] In June 2025, Alembic Pharmaceuticals received final approval for Doxorubicin Hydrochloride Liposome Injection (20 mg/10 mL and 50 mg/25 mL), a generic version of Doxil, indicated for certain cancers.[12] In August 2025, it obtained final approval for Tretinoin Cream USP 0.025%, equivalent to Retin-A, for the treatment of acne vulgaris. During this period, the company's cumulative Abbreviated New Drug Application (ANDA) approvals from the US FDA increased from 219 to 223, including both final and tentative approvals.[13] These products were added to the company's portfolio in therapeutic segments such as oncology, cardiovascular diseases, dermatology, and ophthalmology.[14][12]
Products and services
Alembic Pharmaceuticals manufactures and sells pharmaceutical products and active pharmaceutical ingredients (APIs). Its operations include international and domestic formulations, with the latter comprising branded and generic drugs.[9]
Therapies
Alembic Pharmaceuticals has operations in therapy areas, including dermatology, cardiology, gastroenterology, ophthalmology, oncology, orthopedics, anti-infectives, anti-diabetics, gynecology, and treatments for cold and cough.[4] Alembic Pharmaceuticals’s API plants are cGMP-compliant and have received approvals from various international regulatory agencies. The company operates two research and development (R&D) centers and reported an investment of ₹530 crore in R&D as of 31 March 2025.[15]
Animal Health Division
Alembic Pharmaceuticals established its Animal Health Division in 1986. The division develops pharmaceutical products for livestock, poultry, and companion animals. Among its formulations are Sharkoferrol, an oral hematinic, Moxel Inj, a preparation of amoxicillin and cloxacillin, and injectable cephalosporins such as Xceft Inj (ceftiofur sodium) and Mceft Inj (ceftizoxime sodium).[16] In 2024, the division entered into a strategic agreement with Amlan International to distribute mineral-based feed additives for poultry health in India.[17]
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