A Troubled Timeline:
- August 2018: FDA approves Cequa (https://sunpharma.com/wp-content/uploads/2020/12/Press-Release-USFDA-Approval-of-CEQUA.pdf)
- February 2019: investor call held that included an investor pressing the company to explain why there’s a delay in the product’s launch (Alok Dalal: One question on Cequa. Why is it that Cequa has got pushed out to the first quarter? I would you have thought that Cequa would have received priority over Xelpros. Can you clarify this? Abhay Gandhi: Clearly, we will have priority over Xelpros, but unfortunately when we took up the batch for production we had some technical issues. We have more or less identified and have a rectification plan in place. That is the reason why the launch is delayed.) https://sunpharma.com/wp-content/uploads/2020/12/Earnings-Call-Transcript-2.pdf
- October 2019: Sun announces commercial launch (https://sunpharma.com/wp-content/up...he-Treatment-of-Dry-Eye-Disease-in-the-US.pdf)
- May 2021: Sun Pharmaceutical Industries Inc. has initiated a recall of this product to laboratory results that indicate a lower than expected assay and elevated levels of particulate matter for Lot 10009. In addition to Lot 10009, Lot 10006 will also be recalled out of an abundance of caution as is manufactured using the same process, although there are no out of specification laboratory results at this time. Sun initiated shipment of this product on August 26, 2020. https://www.pharmacy.ca.gov/about/recall_alerts/050721_sun.pdf; https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=187440
- March 2021: per the latest Enforcement Report by the US Food and Drug Administration (USFDA), Sun Pharma is recalling Cequa ophthalmic solution, which is used to treat chronic dry eye. The US-based subsidiary of the Mumbai-based drug major is recalling 37,400 cartons (60 vials per carton) of the ophthalmic solution for being "subpotent", [also for presence of particulate matter] the US health regulator said. https://www.business-standard.com/a...products-in-the-us-market-121031400222_1.html; https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=185857
- April 2022: The US health regulator noted that US-based Sun Pharmaceutical Industries Inc is recalling 73,030 boxes of Cequa (cyclosporine ophthalmic solution) for being a "Subpotent Drug" and containing Particulate Matter. https://www.livemint.com/companies/...all-products-in-us-market-11650779384170.html; https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=192920
- September 2023: Health Canada announces that Sun Pharma Canada Inc. is recalling 2 lots of Cequa Ophthalmic Solution (cyclosporine 0.09% w/v) (lot number: 10026, 10027) from wholesalers, retailers and distributor because the stability assay is out of specification in the affected lo. https://recalls-rappels.canada.ca/en/alert-recall/cequa-out-specification Sun Pharmaceutical Industries Inc is recalling two lots of Cequa (cyclosporine ophthalmic solution) 0.09% for subpotency, according to the September 20, 2023, US Food and Drug Administration (FDA) Enforcement Report. https://www.hmpgloballearningnetwork.com/site/pln/news/subpotent-eye-solution-recalled; https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=203258
- 69,707 cartons (lots 10026 and 10027)
- 37,400 cartons (Lot 10007)
- Undisclosed quantity (lots 10006 and 10009)
- 73,030 boxes (Lots 10014 and 10016)