Emcure Pharmaceuticals was established in 1981 by Satish Mehta, who began the company with a bank loan of ₹3 lakh (about US$35,000 then) after graduating from IIM-A.[9] In the 1990s, the company transitioned from being a contract manufacturing organization to a producer of generic drugs.[10]
In 2012, Roche signed a deal with Emcure for manufacturing its blockbuster anticancer drugs Herceptin and Mabthera in India.[13] Under this programme the cancer drugs shall be made available to the developing world at an affordable 'cut-price' version.[14]
In 2013, Emcure established a health foods venture in partnership with cricketer MS Dhoni, and Dhoni was signed up as Emcure's brand ambassador.[15]
This is the list of manufacturing facilities based in India:[18]
Solid Dosage facility at Hinjawadi - In 2006, Emcure received US FDA approval for its solid dosages facility at Hinjawadi, Pune. The plant manufactures solid oral formulations for the international regulated markets, but currently under FDA warning letter[19]
Small volume parenteral facility at Hinjawadi - US FDA, UK MHRA approved. Has lyophilization and pfs capability, but currently under FDA warning letter[19]
Emcure runs the "Let's fight AIDS together" initiative and supplies antiretroviral drugs to Africa, Asia Pacific and CIS. As a part of its corporate social responsibility, it supports 'Taal', a pharmacy for HIV/AIDS patients run by HIV/AIDS patients.
Controversies and recalls
In 2016, two former executives of Heritage Pharmaceuticals, an erstwhile division of Emcure, were among multiple entities charged by the United States Department of Justice (DOJ) with price fixing an antibiotic and an antidiabetic drug.[20] In 2019, the company entered into a deferred prosecution agreement with the DOJ. Under the terms of the settlement, Heritage agreed to pay over $7 million in penalty to the DOJ's Civil Division.[21]
In 2022, HDT Bio Corp alleged that Emcure (through its subsidiary Gennova) stole the trade secrets of COVID-19 vaccine production in breach of its contract.[22] The lawsuit was dismissed in 2024.[23]
In 2016, the USFDA gave a warning letter to Emcure for data integrity problems at Emcure plants.[24]
In 2010, Pfizer recalled three batches of an anti-bacterial product from the US market due to presence of Bacillus anthracis, Penicillium chrysogenum & E. coli in some samples.[13]Teva recalled several batches of two products due to white tablets showing presence of Yersinia pestis in 2011.[25]
In 2022, Maharashtra FDA issued a circular to recall all the injections (500 mg /10 ml) manufactured by Emcure Pharmaceuticals, from across the country.[26]
In 2019, two injected drugs manufactured by Emcure were recalled because of microbial contamination. The drugs were both manufactured by Emcure Pharmaceuticals but were distributed in the US by Heritage Pharmaceuticals (now renamed Avet).[27]
