API and formulations maker, Shilpa Medicare Limited, has received an import alert 66-40 from the US Food and Drug Administration (USFDA) to the company’s formulations facility at Pharma SEZ in Jadcherla in Telangana on February 17, 2021.
The US drug regulator had inspected the Unit-4 of the company’s facility, following which a warning letter was issued to the company on October 9, 2020. An import alert means that the regulator has enough evidence to allow for Detention Without Physical Examination of products that appear to be in violation of the FDA’s laws and regulations.
“The Company has received an Import Alert 66-40 on February 17, 2021, pursuant to the USFDA inspection of the Unit 4, Jadcherla, Telangana facility from Feb 13 - 20 and Feb 24-25, 2020,” the company informed in a regulatory filing.
Major share of the company’s API and Formulations is marked in the most regulated markets such as the US and Europe. The US is a crucial market for the company as it has seen its formulations revenues growing 40 per cent in fiscal 2019-20 primarily driven by product launches.
Its three products have been exempted from the Import Alert - Azacitidine for Injection, Cyclophosphamide Capsules and Erlotinib Tablets, a regulatory filing informed.
“We are committed to address the concerns raised by the USFDA and will work with the US FDA to resolve these issues at the earliest,” it added.
Shilpa Medicare Ltd currently has three manufacturing facilities approved by USFDA - One formulation facility and two API facilities.
None of these facilities except Jadcherla has any outstanding issues with the USFDA at this point of time, the company had informed in its October 2020 filing.
“We uphold quality and compliance with utmost importance and are committed to maintaining cGMP and quality standards across all Shilpa facilities,” the company said.
Shilpa Medicare Limited has registered standalone net profit for the December quarter at ₹17 crore on ₹171 crore net sales from operations. On consolidated basis company’s net profit for the quarter stood at ₹8 crore on consolidated income from operations at ₹179 crore.
For the nine-month period of the fiscal, company posted consolidated net profit of ₹139 crore against ₹122 crore in the same period last year. Consolidated income from operations for the period stood at ₹663 crore (₹569 crore).