Draft:KVK-Tech
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| Submission declined on 30 June 2025 by Timtrent (talk). This submission is not adequately supported by reliable sources. Reliable sources are required so that information can be verified. If you need help with referencing, please see Referencing for beginners and Citing sources. This draft's references do not show that the subject qualifies for a Wikipedia article. In summary, the draft needs multiple published sources that are:
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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]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]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]FDA warning letters
[edit]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]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]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
[edit]- ^ a b c d Fernandez, Bob (May 5, 2022). "A Bucks County drug firm promised to revive the big Lockheed Martin site. Now it's fighting with local officials and faces charges of defrauding the FDA". The Philadelphia Inquirer. Retrieved 2025-12-16.
- ^ Kostelni, Natalie (2015-03-04). "Lockheed Martin sells large Newtown site to pharma company". Philadelphia Business Journal. Retrieved 2025-12-16.
- ^ Seymour, Kara (March 2, 2015). "Lockheed Martin Announces Sale Of Newtown Property". Patch. Retrieved 2025-12-16.
- ^ George, John (September 21, 2016). "FDA approves Lomaira, KVK-Tech weight-loss pill". Philadelphia Business Journal. Retrieved 2025-12-16.
- ^ Sternberg, Charlie (2024-04-10). "Sen-Jam Pharmaceutical Enters Strategic Partnership with KVK-Tech". Contract Pharma. Retrieved 2025-12-16.
- ^ Acosta, Gail (2017-04-27). "Council Rock's District Science Night Set For May 18". Newtown, PA Patch. Retrieved 2025-12-15.
- ^ "KVK-Tech, Inc. - 592387 - 02/11/2020". U.S. Food and Drug Administration. Retrieved 2025-12-16.
- ^ Rees, Victoria (2025-02-03). "FDA sends warning letter to KVK-Tech manufacturing facility". European Pharmaceutical Review. Retrieved 2025-12-16.
- ^ Blankenship, Kyle (October 27, 2020). "FDA nails Pennsylvania generics maker with 2nd warning letter in a year". Fierce Pharma. Retrieved 2025-12-16.
- ^ Park, Brian (2023-10-02). "Concern Over Opioid Tablet Possibly Appearing in Bottle for Antihypertensive Prompts Recall". MPR. Retrieved 2025-12-16.
- ^ Ernst, Diana (August 8, 2021). "Treatment for Pneumocystis Pneumonia Recalled Due to Temperature Control Issue". EMPR. Retrieved 2025-12-16.
- ^ Kiner, Deb (August 10, 2021). "Pneumonia medication for HIV patients recalled after exposure to extreme cold". PennLive. Retrieved 2025-12-16.
- ^ "KVK-Tech pulls batch of beta blockers after finding opioid tablet on packaging line". Fierce Pharma. October 5, 2023. Retrieved 2025-12-16.
- ^ a b Tanenbaum, Michael (2021-06-11). "Bucks County drug maker charged with defrauding FDA, selling unapproved anxiety drugs". PhillyVoice. Retrieved 2025-12-16.
- ^ Sofield, Tom (July 29, 2021). "Newtown Drug Company With Falls Twp. Facility Raided By Feds". Levittown Now. Retrieved 2025-12-16.