UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
October 10, 2024
Date of Report (Date of earliest event reported)
ELITE PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| Nevada | | 001-15697 | | 22-3542636 |
| (State or other jurisdiction | | (Commission | | (IRS Employer |
| of incorporation) | | File Number) | | Identification No.) |
165 Ludlow Avenue, Northvale, New Jersey 07647
(Address of principal executive offices)
(201) 750-2646
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| | |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| | |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
| Common Stock, par value $0.001 per share | | ELTP | | OTCQB |
Item 7.01 Regulation FD Disclosure.
On October 10, 2024, Elite Pharmaceuticals Inc. (“Elite”) announced the Israeli Ministry of Health approval for Elite’s generic version of Adderall®, an immediate-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 10 mg, 20 mg, and 30 mg tablets on October 7, 2024.
Elite will supply the product to Dexcel Pharma (Or Akiva, Israel), the Company’s exclusive distributor, for the Israeli market. The product is a central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
Under the License and Distribution Agreement with Dexcel, Elite will manufacture and package the generic product under Dexcel’s label. Dexcel will provide sales, marketing, and distribution at its expense. Dexcel will pay an agreed upon transfer price for the product and share profits under certain conditions. Elite’s generic Adderall® product is jointly owned by Elite and Mikah Pharma LLC. The first shipment is dependent on the timing of licensee orders, DEA quotas and manufacturing which could take months.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01 and contained in the press release furnished as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and is not incorporated by reference into any of Elite’s filings under the Securities Act of 1933, as amended, or the Securities Act, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: October 10, 2024 | ELITE PHARMACEUTICALS, INC. |
| | |
| | By: | /s/ Nasrat Hakim |
| | | Nasrat Hakim, President and CEO |
