Strides Pharma Science Singapore arm secures USFDA nod for nonsteroidal anti-inflammatory drug
Bangalore: Strides Pharma Global Pte. Limited, a step-down wholly owned subsidiary of Strides Pharma Science Limited in Singapore, has received approval from the United States Food & Drug Administration (USFDA) for Celecoxib Capsules, 100 mg, 200 mg, and 400 mg.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Celebrex Capsules, 100 mg, 200 mg, and 400 mg, of Upjohn US 2 LLC.
Celecoxib is a selective COX-2 inhibitor used for the management of pain and inflammation associated with
various conditions including osteoarthritis, rheumatoid arthritis, acute pain, and dysmenorrhea. Celecoxib
Capsules, 100 mg, 200 mg, and 400 mg have a combined market size of ~US$ 116 Mn as per IMS.
“The approval of Celecoxib Capsules strengthens Strides’ portfolio in the anti-inflammatory therapeutic segment. This approval complements the company’s existing products in the same therapy area and enhances its ability to serve a broader patient population with effective, affordable treatment options,” Strides stated.
The product will be manufactured at the company’s facility in Puducherry.
Medical Dialogues team had earlier reported that Strides Pharma Global Pte. Limited, Singapore, had received approval for Acetaminophen and Ibuprofen Tablets, 125 mg /250 mg (OTC), from the USFDA.
Read also: Strides Pharma Science arm gets USFDA nod for Acetaminophen and Ibuprofen Tablets
Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited
(532531) and National Stock Exchange of India Limited (STAR). The Company mainly operates in the
regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donorfunded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and
two locations in Bengaluru), Italy (Milan), Kenya (Nairobi), and the United States (New York).
Read also: Strides Pharma buys four approved ANDAs from Nostrum Labs for over Rs 17 crore