U.S. Attorney for the District of New Jersey Philip Sellinger announced Wednesday that the Department of Justice (DOJ) and the Drug Enforcement Administration (DEA) reached a settlement agreement with a Somerset-based pharmaceutical manufacturer. The agreement resolves allegations Novel Laboratories violated the Controlled Substances Act.

Novel agreed to pay $2.25 million under the memorandum of agreement, which is in effect for the next three years. There was no determination of liability.

“From Jan. 1, 2019, to Aug. 31, 2021, Novel committed CSA violations involving its failure to account for approximately 3.1 kg oxycodone, 7.7 kg hydrocodone, 30 kg Temazepam,” according to case documents and contentions of the government contained in the settlement agreement. “DEA discovered these violations during on-site inspections of Novel beginning in the summer of 2021.”

Novel is a subsidiary of Lupin Inc. In addition to that dollar amount for the settlement, the company also agreed to improve its operations and remain in compliance with the law, as well as certain training for employees with access to controlled substances.

Sellinger said that manufacturers that work with dangerous and addictive opioids must safeguard the drugs.

“My office is dedicated to holding every level of the opioid distribution chain accountable for failures to properly and account for controlled substances, including manufacturers, distributors, pharmacies, and medical providers to ensure that these drugs are used safely and for legal purposes,” he said.

“This settlement reflects DEA’s commitment to making sure measures are in place to safeguard the community and hold DEA registrants accountable,” said Cheryl Ortiz, special agent in charge for DEA’s New Jersey Field Division. “I commend our Diversion Investigators for bringing this matter to a resolution.”

An attorney representing Novel did not immediately respond to a request for comment regarding the settlement.

See also:

• NJ part of $350M settlement with opioid marketer
• Teva concludes opioid settlement agreement with all 50 states