Strides receives USFDA approval for Ibuprofen OTC Oral Suspension

▴ Strides receives USFDA approval for Ibuprofen OTC Oral Suspension
Ibuprofen will be manufactured at the company’s facility at Bengaluru

Strides Pharma Science Limited 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. 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.

Tags : #StridesPharma #LatestNewsonStridesPharma24thFeb #LatestPharmaNews24thFeb #LatestUSFDAApproval24thFeb #IbuprofenRelievesPain #JohnsonJohnson

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

How a Fiber-Rich Diet and Gut Parasites Can Improve Your HealthJuly 16, 2024
LinkedIn: A Double-Edged Sword for Professional GrowthJuly 16, 2024
Food Safety and Drug Administration (FDA), Uttarakhand, National Association of Street Vendors of India (NASVI) and Nestlé India expand Project ‘Serve Safe Food’ in Uttarakhand July 16, 2024
IIT Kharagpur and University of Leeds Sign MoU for Joint Supervision of PhD ProgramsJuly 16, 2024
Puja Curtains go up with KHUTI PUJA at Hazra Park DurgotsabJuly 16, 2024
Algorand and SEWA Join Forces to Launch Digital Health Passport Initiative for Women's EmpowermentJuly 15, 2024
The Debate Over Menstrual Leave: Balancing Needs and Workplace EqualityJuly 15, 2024
Young Indians Face Higher Lung Cancer Risk: Insights and ImplicationsJuly 15, 2024
Honoring a Healthcare Pioneer: Indian-origin Dr. George Matthew's Legacy in the UAEJuly 15, 2024
The Role of Platelets and Monocytes: New Research InsightsJuly 13, 2024
Groundbreaking Discovery in Cancer Research: Over 5,000 Genetic Variations IdentifiedJuly 13, 2024
June 2024: The Hottest Month on Record and What It Means for Our PlanetJuly 13, 2024
Cambodia Angkor Air teams up with Çelebi India for Cargo OperationsJuly 12, 2024
QUOTE ON UNION BUDGET EXPECTATIONS JULY 2024July 12, 2024
Empowering Consumers with Nutritional Information: FSSAI's New Labeling GuidelinesJuly 12, 2024
Innovative Migraine Research Uncovers Key Triggers and Pathways for PainJuly 12, 2024
Alarming Rise in Death's Due to HIV Among Students in Tripura: Urgent Need for ActionJuly 12, 2024
Amrita Vishwa Vidyapeetham is All Set to Produce Netravaad, an Innovative Technology for Speech Impairment July 11, 2024
Twice-Yearly Injection Shows 100% HIV Protection in Young WomenJuly 11, 2024
AIMS (Asian Hospital) Doctors Restore Disfigured Face of Road Accident VictimJuly 10, 2024