USFDA8 Dec 2025, 03:38 pm
Caplin Point's Subsidiary, Caplin Steriles, Receives USFDA Approval for Acetaminophen Injection
AI Summary
Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Limited, has been granted final approval from the USFDA for its ANDA Acetaminophen Injection, 1000 mg/100 mL (10 mg/mL) Single-dose Infusion Bags. This generic therapeutic equivalent version of the RLD from Mallinckrodt Pharmaceuticals Ireland Limited is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever in adult and pediatric patients. According to IQVIA™, Acetaminophen Injection had US sales of approximately $86 million for the 12-month period ending October 2025.
Key Highlights
- Caplin Steriles Limited receives final approval from USFDA for Acetaminophen Injection
- Acetaminophen Injection is indicated for pain management and fever reduction in adult and pediatric patients
- The drug had US sales of approximately $86 million for the 12-month period ending October 2025
- Caplin Steriles Limited is a fast growing sterile product manufacturing company
- Caplin Point Laboratories Limited is a fast-growing pharmaceutical company with a unique business model catering to emerging markets