Strides Pharma bags USFDA nod for pain relief drug

The medicine will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

Published On 2022-05-30 06:21 GMT   |   Update On 2022-05-30 06:21 GMT
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Bengaluru: Strides Pharma Science Limited today announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Ibuprofen Oral Suspension USP, 100 mg/5 mL from the United States Food & Drug Administration (USFDA).

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu.

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The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare.

Read also: Strides Pharma gets USFDA okay for Amantadine Hydrochloride Softgel Capsules

The medicine will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

According to IQVIA MAT March 2022 data, the US market for Ibuprofen Oral Suspension USP, 100 mg/5 mL is approximately ~US$ 66 Mn.

The company has 274 cumulative ANDA filings (including recently acquired portfolio from Endo at Chestnut Ridge) with USFDA of which 250 ANDAs have been approved and 24 are pending approval. The company currently has ~60 commercialized products in the US and has set a target to launch ~ 20 new products every year from the combined portfolio.

Read also: Strides: Dr R Ananthanarayanan to depart as MD, Arun Kumar to take charge

Strides is a global pharmaceutical company headquartered in Bengaluru, India.
The Company mainly operates in the regulated markets and has an "in Africa for Africa" strategy along with an institutional business to service donor-funded markets. The Company's global manufacturing sites are located in India (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the United States (New York).
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