Caplin Steriles bags USFDA nod for Ketorolac Tromethamine Injection

Ketorolac Tromethamine Injection USP is a nonsteroidal anti-inflammatory drug (NSAID), indicated for the short-term management of moderately severe acute pain.

Published On 2023-05-12 09:05 GMT   |   Update On 2023-05-12 09:05 GMT
Advertisement

Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL Single-dose Vial.

The product is a generic therapeutic equivalent version of (RLD), TORADOL injection of Roche.

Advertisement

Ketorolac Tromethamine Injection USP is a nonsteroidal anti-inflammatory drug (NSAID), indicated for the short-term (≤5 days) management of moderately severe acute pain.

According to IQVIA (IMS Health), Ketorolac Tromethamine Injection USP had US sales of approximately $53 million for the 12-month period ending December 2022.

Mr. C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited commented “Our regulated markets business continues to grow at a robust pace, and this new approval will help augment the growth. We have also received a few approvals from other markets such as Canada and Australia and we look forward to launches there within this year too.”

Read also: USFDA nod to Caplin Steriles Rocuronium Bromide Injection

Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a niche sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP and ANVISA. Caplin Steriles Limited, has developed and filed 30 ANDAs in USA on its own and with partners, with 21 approvals so far. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products, that it intends to file over the next 4 years.
Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News