AMRI Revenue Grows as Large Scale Manufacturing, Discovery Services Ramp Up
This was the third consecutive quarter of revenue growth for the Albany, NY-based contract manufacturer and CFO and treasurer Michael Nolan said the company continues to expect “to be profitable excluding royalties by the end of the year.” Large scale manufacturing helped
Despite the positives in the latest earnings report, the company’s stock ended the day down 6% and was down as much as 12% after the earnings were released.
AMRI President and CEO Thomas E. D’Ambra said in a conference call on Tuesday that the company is “still seeing some softness overall, reflected in companies having budgetary problems,” but there is “increased interest in custom libraries and early discovery services, which had been soft in the not-too-distant past,” and there are some positive signs to suggest funding is returning to early R&D budgets.
Recent Form 483
D’Ambra added that in July the company’s Burlington, Massachusetts, aseptic fill finish operation was inspected by the FDA “resulting in limited-scope findings, including no observations related to corrective actions previously implemented.”
He also said the company submitted a written response to the Form 483 on Monday and the FDA’s district office is expected to take 15 days to evaluate the company’s response, though the company may not hear a response from the agency for another few months on whether or not the FDA will lift the warning letter the site received in August 2010. He noted that the company is still experiencing “some of the headwinds” from that warning letter.
The site has been problematic for the company since it was acquired through the takeover of Hyaluron in 2010. However, the facility recently received US DEA (Drug Enforcement Agency) approval to work with Schedule 2 controlled substances.
Other Developments
AMRI’s Aurangabad, India facility received certification in India from the Central Drugs Standard Control Organization, to export certain generic APIs made at the plant to Europe. The certification confirms the facility complies with EU GMP (good manufacturing practice) guidelines.
