Which manufacturer was DefenCath approved with, and what happened to the alternatives?

FDA Complete Response Letter, February 26, 2021 · page 8

During a review of records requested under Federal Food, Drug, and Cosmetic Act section 704(a)(4), provided by Rovi Pharma Industrial Services S.A. (FEI 3016688535) manufacturing facility, the FDA noted objectionable conditions. These objectionable conditions will be conveyed to the representative of the facility within 10 business days of issuance of this Complete Response letter. Satisfactory resolution of these objectionable conditions is required (e.g., preapproval inspection and/or adequate facility responses addressing these conditions) before this application may be approved.

CorMedix Form 8-K, filed August 9, 2022

has entered into an agreement with Alcami Corporation, a US based contract manufacturer with proven capabilities for manufacturing commercial sterile parenteral drug products, which will serve as an alternative manufacturing site for DefenCath. The Company has been working with Alcami over the past several months to transfer the manufacturing process for DefenCath into an Alcami site, and CorMedix expects to be able to submit a supplement to its NDA application around the end of the first quarter of 2023.

CorMedix Form 8-K, filed March 3, 2023

CMO 2 + API 2: The Company previously guided to the availability of data for submission from an alternate CMO in the first half of 2023; however, due to delays in completing validation, these data are expected to be available by the end of the 3 rd quarter of 2023. The Company remains focused on pathways #1 and #2 as its primary strategy, and currently intends to utilize pathway #3 as a back-up manufacturing site.

CorMedix Form 8-K, filed March 3, 2023

CMO 1 + API 1: This scenario potentially remains the fastest pathway to NDA resubmission and approval, provided FDA concurs that CMO 1 has remediated its compliance deficiencies and that the DMF for API 1 can be utilized prior to full resolution of the existing warning letter. CorMedix hopes to obtain guidance from FDA on these two important issues in a Type A meeting. The Company intends to resubmit the application as soon as possible following FDA’s positive guidance on these two issues. Given that no new data would be contained in this resubmission, provided no additional site inspections are required, the Company believes this may be classified as a Class 1 submission with a 60-day review.

CorMedix Form 8-K, filed March 30, 2023

CorMedix announced an agreement to validate manufacturing of DefenCath at Siegfried AG’s site in Hameln, Germany, which has previously been inspected by FDA. The Hameln site previously manufactured Neutrolin®, which was sold in Europe as a medical device. The Company intends to utilize Siegfried as a back-up CMO.

CorMedix Form 8-K, filed April 26, 2023

Based on guidance from FDA, CorMedix will resubmit the NDA with manufacturing data generated at CMO 1 and utilizing both the existing source of heparin API (“API 1”) as well as a new supplier of Heparin API (“API 2”). The Company has completed the validation of the manufacturing process using API 2, and believes all batches have met product specifications. Data for submission are currently available and resubmission is targeted for mid-May following receipt of final Type A meeting minutes. As part of validation of manufacturing with this API, the Company will be adding a 3 mL single-dose vial to its 5 mL commercial presentation to meet market preferences and demand. As the submission will contain new manufacturing information, the Company expects it to be classified as a Class 2 resubmission with a 6-month review.

CorMedix Form 8-K, filed April 26, 2023

At the Type A meeting, the FDA informed CorMedix that it is in receipt of the close out report for inspectional observations received from its existing contract manufacturing organization (“CMO 1”), and NDA resubmission with CMO 1 can be done at the Company’s discretion. The FDA may conduct a pre-approval inspection at the facility as part of the NDA review process.

CorMedix Form 8-K, filed June 21, 2023

today announced that the resubmission of the New Drug Application (NDA) for DefenCath has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Agency considers the resubmission as a complete, Class 2 response with a six-month review, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 15, 2023.

CorMedix Form 8-K, filed November 14, 2023

The FDA completed a preapproval inspection for CorMedix’s primary finished dosage CMO site in September and the Company is pleased with the outcome. In addition, the FDA has also conducted preapproval inspections for DefenCath at suppliers of active pharmaceutical ingredients, contract laboratories involved in testing of product specifications and packaging facilities, and CorMedix is not aware of any outstanding deficiencies or review issues at this time.

CorMedix Form 10-K, filed March 5, 2026

On November 15, 2023, we announced that the FDA approved the new drug application (“NDA”) for DefenCath, an antimicrobial catheter lock solution (“CLS”) (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) indicated to reduce the incidence of catheter-related bloodstream infections (“CRBSI”) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (“CVC”). We launched DefenCath commercially in April 2024 in the inpatient setting and July 2024 in the outpatient hemodialysis setting, and it is the largest contributor to our net sales.

CorMedix Form 10-K, filed March 5, 2026

The Company received FDA approval of DefenCath with finished dosage production from its European based CMO Rovi Pharma Industrial Services. In addition, the Company also qualified Siegfried Hameln as an alternate finished dosage manufacturing site and is in the process of scaling production at the facility.