Strides gets USFDA Yes for Ibuprofen OTC Oral Suspension

Ibuprofen Oral Suspension USP,100 mg/5 mL (OTC) further strengthens company’s private label portfolio for the US market.

55
USFDA
Picture: Pixabay

Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Ibuprofen Oral Suspension USP,100 mg/5 mL (OTC) from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Children’s Motrin® Oral Suspension, 100 mg/mL, of Johnson & Johnson Consumer Inc.

Strides is focusing on building a private label business in the US by leveraging its portfolio of products across soft gels, tablets, capsules, topicals, powders and oral solutions.


Also read | IPC to expand Pharmacovigilance Programme of India in J&K: Focus on…


Ibuprofen Oral Suspension USP,100 mg/5 mL (OTC) further strengthens company’s private label portfolio for the US market.

According to IRi data, the US market for Ibuprofen Oral Suspension USP,100 mg/5 mL (OTC) is approximately US$ 133 Mn. The product will be manufactured at the company’s facility at Bengaluru.  

The company has 127 cumulative ANDA filings with USFDA of which 99 ANDAs have been approved and 28 are pending approval.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain from various conditions such as headache, dental pain, muscle aches.

It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu.


Also read:

Sun Pharma to launch entire range of Epilepsy treatment drug in India

Dr Reddy’s launch Lansoprazole DR orally disintegrating tablets

Unichem gets USFDA approval for Apremilast Tablets

Lupin gets USFDA nod to market generic Droxidopa capsules

Aurobindo Pharma gets USFDA nod for generic Droxidopa capsules


The Health Master is now on Telegram. For latest update on health and Pharmaceuticals, subscribe to The Health Master on Telegram.

Go to main website, click here

Follow and connect with us on Facebook and Linkedin

Subscribe for daily free updates, click here

For daily free updates on WhatsApp, click here

Subscribe here for daily updates
Loading