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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
November
12, 2025
Date
of Report (Date of earliest event reported)
ELITE
PHARMACEUTICALS INC /NV/
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)) |
| |
|
| ☐ |
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
November 12, 2025, in a press release, Elite Pharmaceuticals, Inc., or Elite, reported that it received approval from the US Food and
Drug Administration (FDA) for a generic version of Requip XL® (Ropinirole Extended-Release Tablets USP), with strengths of 2 mg,
4 mg, 6 mg, 8 mg, and 12 mg tablets. Ropinirole belongs to a class of drugs known as a non-ergoline dopamine agonist used to treat symptoms
of Parkinson’s disease. This product will be marketed and sold under the Elite Laboratories, Inc. label.
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.
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release dated November 12, 2025 |
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document). |
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:
November 12, 2025 |
ELITE
PHARMACEUTICALS, INC. |
| |
|
|
| |
By: |
/s/
Nasrat Hakim |
| |
|
Nasrat
Hakim, President and CEO |
