Emcure Pharmaceuticals Limited (Emcure) is an Indian multinational pharmaceutical company, headquartered in Pune. Emcure's product portfolio includes tablets, capsules (both softgel capsules and hard-gel capsules) and injectables.[1][2] The company produces gynaecology, cardiovascular, oncology and blood therapeutic drugs, HIV antivirals and other anti-infectives, and vitamins and minerals.[3][4]
History
Emcure Pharmaceuticals was established in 1981 by Satish Mehta, who began the company with a bank loan of Template:INR3 lakh (about US$35,000 then) after graduating from IIM-A.[5] In the 1990s, the company transitioned from being a contract manufacturing organization to a producer of generic drugs.[6]
In 2006, Emcure signed license agreements with Bristol-Myers Squibb for Atazanavir[7] and Gilead Sciences for Tenofovir as part of their Global Access Programs.[8]
In 2012, Roche signed a deal with Emcure for manufacturing its blockbuster anticancer drugs Herceptin and Mabthera in India.[9] Under this programme the cancer drugs shall be made available to the developing world at an affordable 'cut-price' version.[10]
In 2013, Emcure established a health foods venture in partnership with cricketer MS Dhoni, and Dhoni was signed up as Emcure's brand ambassador.[11]
In 2014, Blackstone sold its 13% stake in Emcure to Bain Capital.[12]
In 2021, Emcure demerged its US-based business, including subsidiary Heritage Pharmaceuticals, into a new company called Avet Lifesciences.[13]
In 2024, Emcure launched its initial public offering, and listed on NSE and BSE.[14]
Operations
Indian plants
This is the list of manufacturing facilities based in India:[15]
- 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[16]
- Small volume parenteral facility at Hinjawadi - US FDA, UK MHRA approved. Has lyophilization and pfs capability, but currently under FDA warning letter[16]
- Oncology injectable facility at Hinjawadi, but currently under FDA warning letter[16]
- Solid Orals facilities at Jammu and Bhosari
- API facility at Kurkumbh- US FDA approved
- Biotech facility at Hinjawadi
- R&D Center at Gandhinagar and plant at Sanand, Ahmedabad.- Sanand facility is US FDA approved
US plant
USA - The company has a manufacturing facility and R&D center in East Brunswick, New Jersey, USA.[15]
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.[17] 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.[18]
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.[19] The lawsuit was dismissed in 2024.[20]
In 2016, the USFDA gave a warning letter to Emcure for data integrity problems at Emcure plants.[21]
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.[9] Teva recalled several batches of two products due to white tablets showing presence of Yersinia pestis in 2011.[22]
In 2022, Maharashtra FDA issued a circular to recall all the injections (500 mg /10 ml) manufactured by Emcure Pharmaceuticals, from across the country.[23]
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).[24]
See also
References
- ↑ Emcure Pharmaceuticals | Leading Global Pharmaceutical Company. Emcure. Retrieved 2021-08-23.
- ↑ Emcure Pharmaceuticals. The Economic Times. Retrieved 2021-08-23.
- ↑ Cite error: Invalid
<ref>tag; no text was provided for refs namedRevenue - ↑ Emcure Pharmaceuticals Ltd. Bloomberg. Retrieved 28 June 2024.
- ↑ A cure from Mr Mehta. The Times of India(28 October 2003). Retrieved 3 July 2024.
- ↑ Satish Mehta & family. Forbes. Retrieved 10 July 2024.
- ↑ Bristol-Myers outsources AIDS drug to Emcure. Business Standard India(17 February 2006).
- ↑ Gilead Sciences in pact with drug trio. The Telegraph(16 August 2006). Retrieved 27 June 2024.
- ↑ 9.0 9.1 Business News Today: Read Latest Business news, India Business News Live, Share Market & Economy News. The Economic Times.
- ↑ Roche to Sell Cheaper Cancer Drugs in India | Businessworld. Retrieved 2012-04-12.
- ↑ MS Dhoni to sell health drink, energy bars in partnership with Emcure Pharmaceuticals. The Economic Times(13 March 2013). Retrieved 3 July 2024.
- ↑ Blackstone to sell Emcure Pharmaceuticals stake to Bain Capital - Indian Express. archive.indianexpress.com.
- ↑ Cite error: Invalid
<ref>tag; no text was provided for refs namedcrisil - ↑ Emcure Pharma shares debut with 31% premium over issue price. The Economic Times(10 July 2024). Retrieved 10 July 2024.
- ↑ 15.0 15.1 Manufacturing | Emcure Pharmaceuticals. Emcure(29 July 2021). Retrieved 2021-08-23.
- ↑ 16.0 16.1 16.2 Emcure Pharmaceuticals Limited - 576961 - 08/02/2019. Food and Drug Administration(5 October 2020).
- ↑ 2 ex-executives of Emcure's US arm accused of price fixing. Business Standard. Retrieved 27 June 2024.
- ↑ Pharmaceutical Company Admits to Price Fixing in Violation of Antitrust Law, Resolves Related False Claims Act Violations. www.justice.gov(31 May 2019).
- ↑ Lawsuit says India's Emcure stole COVID-19 vaccine secrets for IPO. Reuters(22 March 2022).
- ↑ Emcure and its subsidiary Gennova settle legal dispute with HDT Bio over mRNA technology. The Economic Times(23 May 2024). Retrieved 27 June 2024.
- ↑ FDA Warns Indian Pharma Company Over Repeat Data Manipulation Violations. raps.org. Retrieved 27 June 2024.
- ↑ March 2011. Retrieved 2012-04-25.
- ↑ FDA recalls Orofer FCM after Saifee patient's death. Hindustan Times. Retrieved 27 June 2024.
- ↑ FDA asks Emcure to recall contaminated injectable drugs