Draft:KVK-Tech
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- File:Symbol opinion vote.svg Comment: Your references major om PR churnalism, which is unacceptable. Please replace these with good, useful referencing. 🇵🇸🇺🇦 FiddleTimtrent FaddleTalk to me 🇺🇦🇵🇸 23:46, 30 June 2025 (UTC)
| Company type | Private |
|---|---|
| Industry | Pharmaceutical manufacturing |
| Founded | 2004 |
| Founder | Murty Vepuri |
| Headquarters | Newtown, Pennsylvania, United States |
Key people | Anthony Tabasso (CEO) |
| Products | Generic drugs |
| Website | kvktech |
KVK-Tech, Inc. is an American generic drug manufacturer headquartered in Newtown, Pennsylvania.[1]
History
[edit | edit source]KVK-Tech was founded in 2004 by Murty Vepuri, who previously operated Able Laboratories in New Jersey. Between 2006 and 2012, KVK-Tech was among the largest manufacturers of generic opioid medications in the United States, producing 580 million pills.[1]
In March 2015, KVK-Tech purchased a 52-acre former Lockheed Martin corporate campus in Newtown Township for $12.5 million.[2][3]
In September 2016, the FDA approved the company's first branded product, KVK-Tech's Lomaira (phentermine) 8mg tablets for weight reduction.[4]
As of 2022, KVK-Tech operates multiple facilities in Pennsylvania, including its headquarters at 110 Terry Drive in Newtown Township, the former Lockheed Martin campus at 100 Campus Drive in Newtown Township, and a manufacturing facility in Falls Township.[1]
In 2023, KVK-Tech entered into strategic partnerships with Sen-Jam Pharmaceutical for the development, manufacturing, and distribution of pharmaceutical products.[5]
Community programs
[edit | edit source]Since 2017, KVK-Tech has partnered with the Council Rock School District in Bucks County, Pennsylvania, to support STEM education programs.[6]
Regulatory issues and recalls
[edit | edit source]FDA warning letters
[edit | edit source]In February 2020, the FDA issued a warning letter to KVK-Tech's headquarters facility after an April 2019 inspection found violations of current good manufacturing practices (cGMP), including impurity levels and foreign objects in medication lots.[7][8]
In October 2020, the FDA issued a second warning letter to KVK-Tech's facility at the former Lockheed Martin campus after a February-March 2020 inspection identified additional cGMP violations, including inadequate cleaning validation procedures.[9]
Product recalls
[edit | edit source]In July 2021, KVK-Tech issued a voluntary nationwide recall of one lot of betaxolol tablets after a single foreign tablet was discovered during line clearance after packaging.[10]
In August 2021, the company recalled two lots of atovaquone oral suspension used to treat Pneumocystis pneumonia in HIV/AIDS patients due to a temperature control issue during shipping.[11][12]
In October 2023, KVK-Tech recalled a batch of losartan potassium/hydrochlorothiazide tablets after an oxycodone tablet was found in a bottle of the blood pressure medication.[13]
Criminal charges
[edit | edit source]In June 2021, the United States Department of Justice charged KVK-Tech, Murty Vepuri, and quality assurance director Ashvin Panchal with conspiracy to defraud the FDA.[14] The indictment alleged that from October 2010 through March 2015, the company distributed more than 383,000 bottles of hydroxyzine, an anxiety medication, using an unapproved active pharmaceutical ingredient (API) from a Dr. Reddy's Laboratories facility in Mexico that was under an FDA import alert due to manufacturing violations.[14]
In 2022, U.S. District Judge Harvey Bartle III dismissed part of the charges, ruling that the use of the Mexican manufacturing location did not constitute distributing a new drug, as the API had the same chemical composition as approved sources.[1]
In July 2021, federal agents conducted searches at KVK-Tech facilities in Newtown and Falls Township, seizing 30 terabytes of digital information and 500 boxes of company records.[15]
References
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External links
[edit | edit source]- Pending AfC submissions
- Pending AfC submissions in article space
- AfC submissions by date/15 December 2025
- AfC submissions by date/21 June 2025
- Pharmaceutical companies of the United States
- Companies based in Bucks County, Pennsylvania
- Generic drug manufacturers
- Pharmaceutical companies established in 2004
- 2004 establishments in Pennsylvania
- Privately held companies based in Pennsylvania