Filing Analysis
Elite Pharmaceuticals filed an amended 8-K (8-K/A) to correct the date of a previously announced conference call regarding Q1 fiscal year 2027 financial results. The company is correcting the meeting date from November to August.
🚩 Red Flags
- None identified; this is an administrative correction of a date.
📋 Key Facts
- The filing is an amendment (8-K/A) specifically to correct deadlines in a previous report.
- Conference call to discuss Q1 fiscal year 2027 results (ended June 30, 2026) was rescheduled from November to August 14, 2026.
- The conference call is scheduled for 11:30 AM EDT on August 14, 2026.
- The company issued a press release (Exhibit 99.1) regarding the financial results discussion.
Elite Pharmaceuticals, Inc. filed an 8-K to announce a scheduled conference call to discuss financial results for the first quarter of fiscal year 2027.
📋 Key Facts
- Conference call date: November 14, 2026, at 11:30 AM EDT.
- The call will focus on Q1 FY2027 results (ended June 30, 2026).
- Press release issued on August 10, 2026, is incorporated by reference as Exhibit 99.1.
Elite Pharmaceuticals announced the launch of its generic version of Requip XL (Ropinirole Extended-Release Tablets USP) in multiple strengths. The product is marketed under the Elite Laboratories, Inc. label for the treatment of Parkinson's disease.
📋 Key Facts
- Product: Generic version of Requip XL® (Ropinirole Extended-Release Tablets USP).
- Strengths available: 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg tablets.
- Indication: Parkinson's disease (non-ergoline dopamine agonist).
- Marketing Label: Elite Laboratories, Inc.
Elite Pharmaceuticals, Inc. filed an 8-K to announce the filing of its Form 10-K for the fiscal year ended March 31, 2026, and the subsequent release of its annual financial results.
📋 Key Facts
- Company filed its annual report (Form 10-K) for the fiscal year ending March 31, 2026.
- A press release detailing financial results was issued on June 29, 2026.
- Management scheduled a conference call and business update for June 30, 2026, at 11:30 AM EDT.
Elite Pharmaceuticals, Inc. filed an 8-K to announce the filing of its quarterly report on Form 10-Q for the period ended September 30, 2025, and a subsequent press release regarding financial results.
📋 Key Facts
- Filed Form 10-Q for the quarter ended September 30, 2025 (fiscal year 2026).
- Scheduled a conference call/business update for November 17, 2025, at 11:30 AM EST.
- The company will address stockholder questions during the upcoming call.
This is an 8-K/A (amendment) filed by Elite Pharmaceuticals to correct a clerical error regarding the date of a scheduled conference call. The company intends to discuss its Q2 fiscal year 2026 financial results on November 17, 2025.
🚩 Red Flags
- None identified in this specific amendment; it is purely administrative/clerical.
📋 Key Facts
- Filing is an amendment (8-K/A) to a previous filing from November 10, 2025.
- The sole purpose of the amendment is to correct the date of the conference call mentioned in Item 7.01.
- Conference call scheduled for Monday, November 17, 2025, at 11:30 AM EST.
- The call will discuss financial results for the second quarter of fiscal year 2026 (ended September 30, 2025).
- Includes dial-in instructions and a deadline for submitting questions.
Elite Pharmaceuticals received FDA approval for a generic version of Requip XL (Ropinirole Extended-Release Tablets USP) in multiple strengths. The product will be marketed under the Elite Laboratories, Inc. label.
📋 Key Facts
- FDA approved generic Ropinirole Extended-Release Tablets USP (Requip XL®).
- Strengths approved: 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg tablets.
- Product to be marketed/sold under Elite Laboratories, Inc. label.
- Filing date: November 12, 2025.
Elite Pharmaceuticals, Inc. announced a conference call scheduled for November 14, 2025, to discuss the company's financial results for the second quarter of fiscal year 2026.
📋 Key Facts
- Conference call date: Friday, November 14, 2025, at 11:30 AM EST.
- Purpose: To discuss Q2 fiscal year 2026 financial results (ended September 30, 2025).
- The filing includes a press release as Exhibit 99.1.
Elite Pharmaceuticals, Inc. filed an 8-K to announce the filing of its quarterly report on Form 10-Q for the period ended June 30, 2025, and a subsequent press release regarding financial results.
📋 Key Facts
- Filed Form 10-Q for the quarter ended June 30, 2025 (fiscal year 2026).
- Scheduled a conference call/business update for August 15, 2025, at 11:30 AM EDT.
- The company will host a Q&A session during the scheduled call to address stockholder questions.
Elite Pharmaceuticals, Inc. announced a conference call scheduled for August 15, 2025, to discuss the company's financial results for the first quarter of fiscal year 2026 ended June 30, 2025.
📋 Key Facts
- Conference call date: Friday, August 15, 2025, at 11:30 AM EDT.
- Purpose: To discuss Q1 fiscal year 2026 financial results (ended June 30, 2025).
- The filing includes a press release as Exhibit 99.1.
Elite Pharmaceuticals, Inc. filed an 8-K to announce the filing of its annual report on Form 10-K for the fiscal year ended March 31, 2025, and a corresponding press release regarding financial results.
📋 Key Facts
- Company filed its year-end report on Form 10-K for the fiscal year ended March 31, 2025.
- The filing includes a press release (Exhibit 99.1) announcing financial results.
- A conference call and business update is scheduled for July 1, 2025, at 11:30 AM EDT.
Elite Pharmaceuticals, Inc. announced a conference call scheduled for July 1, 2025, to discuss the company's financial results for the fiscal year ended March 31, 2025.
📋 Key Facts
- Conference call date: July 1, 2025, at 11:30 AM EDT.
- Purpose of call: To discuss financial results for the fiscal year ended March 31, 2025.
- The filing includes a press release (Exhibit 99.1) regarding the upcoming earnings discussion.
Elite Pharmaceuticals reported positive bioequivalence study results for an undisclosed generic anticoagulant drug. The company intends to use this data to file an Abbreviated New Drug Application (ANDA) with the FDA.
🚩 Red Flags
- The specific drug product remains undisclosed, creating information asymmetry for investors regarding the market size and competition.
📋 Key Facts
- Positive results from a pivotal bioequivalence study for an undisclosed generic anticoagulant medication.
- The study was open-label, randomized, balanced, single oral dose, two-treatment, two-period, two-sequence, crossover in healthy human subjects under fasting conditions.
- Elite is compiling data to file an Abbreviated New Drug Application (ANDA) with the FDA.
- Report filed on June 16, 2025.
Elite Pharmaceuticals announced the launch of its generic version of Percocet® (oxycodone hydrochloride and acetaminophen tablets) in three strengths: 5mg/325mg, 7.5mg/325mg, and 10mg/325mg. The product is marketed under the Elite Laboratories, Inc. label.
📋 Key Facts
- Product launch: Generic Percocet® (oxycodone hydrochloride and acetaminophen tablets, USP CII).
- Strengths available: 5mg/325mg, 7.5mg/325mg, and 10mg/325mg.
- Marketing label: Elite Laboratories, Inc.
- Filing date: April 30, 2025.
Elite Pharmaceuticals announced the shipment of its first lot of finished product from its new FDA-approved expanded campus. This is a regulatory/operational milestone communicated via Regulation FD disclosure.
📋 Key Facts
- The company has completed shipments from its new FDA-approved expanded campus.
- This marks the 'first lot' of finished products to be shipped from the new facility.
- The announcement was made via a press release on March 3, 2025.
Elite Pharmaceuticals, Inc. filed an 8-K to announce the filing of its quarterly report on Form 10-Q for the period ending December 31, 2024. The company also scheduled a conference call and business update for February 14, 2025.
📋 Key Facts
- Filed Form 10-Q for the quarter ended December 31, 2024.
- Issued a press release announcing financial results on February 13, 2025.
- Scheduled a conference call and general business update for February 14, 2025, at 11:30 AM EST.
Elite Pharmaceuticals announced the launch of its generic version of Vyvanse (Lisdexamfetamine Disylate) in multiple strengths for the treatment of ADHD. The product is being marketed under the Elite Laboratories, Inc. label.
📋 Key Facts
- Product: Generic version of Vyvanse® (Lisdexamfetamine Disylate).
- Indications: Treatment of Attention Deficit Hyperactivity Disorder (ADHD).
- Dosage Strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg capsules.
- Marketing Label: Elite Laboratories, Inc.
Elite Pharmaceuticals announced the launch of its generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets) in multiple strengths. The product is being marketed under the Elite Laboratories, Inc. label.
📋 Key Facts
- Product: Generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets, USP CII).
- Dosages launched: 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg, and 10mg/325mg tablets.
- Marketing Label: Elite Laboratories, Inc.
Elite Pharmaceuticals, Inc. announced that the FDA approved a generic version of Vyvanse® (Lisdexamfetamine Dimesylate) in multiple strengths on November 15, 2024. The product will be marketed under the Elite Laboratories, Inc. label.
📋 Key Facts
- FDA approval received on November 15, 2024.
- Product: Generic version of Vyvanse® (Lisdexamfetamine Dimesylate).
- Strengths approved: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg capsules.
- Indication: Treatment of Attention Deficit Hyperactivity Disorder (ADHD).
- Marketing label: Elite Laboratories, Inc.
Elite Pharmaceuticals, Inc. filed an 8-K to announce the filing of its quarterly report on Form 10-Q for the period ending September 30, 2024. The company also scheduled a conference call and business update for November 15, 2024.
📋 Key Facts
- Filed Form 10-Q for the quarter ended September 30, 2024 on November 14, 2024.
- Scheduled a conference call and general business update for November 15, 2024, at 11:30 AM EST.
- The company will address stockholder questions during the scheduled call.
Elite Pharmaceuticals announced that the Israeli Ministry of Health has approved its generic version of Adderall® (amphetamine salts) for use in Israel. The company will manufacture and package the product under a license with Dexcel Pharma, which will handle sales and distribution.
🚩 Red Flags
- Revenue timing uncertainty: First shipment depends on DEA quotas and manufacturing cycles, potentially delaying cash flow for months.
📋 Key Facts
- Israeli Ministry of Health approval received on October 7, 2024, for generic Adderall® (10mg, 20mg, and 30mg tablets).
- Product is a CNS stimulant indicated for ADHD and Narcolepsy.
- Dexcel Pharma (Israel) will act as the exclusive distributor, handling sales, marketing, and distribution at its own expense.
- Elite Pharmaceuticals will manufacture and package the product under Dexcel's label.
- The product is jointly owned by Elite Pharmaceuticals and Mikah Pharma LLC.
- Revenue realization is subject to DEA quotas, licensee orders, and manufacturing timelines, which may take several months.
Elite Pharmaceuticals announced the launch of its generic version of Tylenol® with Codeine (acetaminophen and codeine phosphate) in three different strengths. The product is marketed under the Elite Laboratories, Inc. label.
📋 Key Facts
- Product: Generic Tylenol® with Codeine (acetaminophen and codeine phosphate).
- Dosage Strengths: 300mg/15mg, 300mg/30mg, and 300mg/60mg tablets.
- Labeling: Marketed and sold under the Elite Laboratories, Inc. label.
- Filing Date: October 7, 2024.
Elite Pharmaceuticals announced the launch of its generic methotrexate sodium 2.5 mg tablets, marketed under the Elite Laboratories, Inc. label.
📋 Key Facts
- Product Launch: Generic methotrexate sodium 2.5 mg tablets.
- Marketing Label: Sold under the 'Elite Laboratories, Inc.' brand.
- Filing Date: August 27, 2024.
Elite Pharmaceuticals, Inc. filed an 8-K to announce the filing of its quarterly report on Form 10-Q for the period ended June 30, 2024, and to schedule a conference call for August 15, 2024.
📋 Key Facts
- Filed Form 10-Q for the quarter ended June 30, 2024.
- Scheduled a business update conference call for August 15, 2024, at 11:30 AM EDT.
- The company will address stockholder questions during the scheduled call.
Elite Pharmaceuticals, Inc. filed an 8-K to announce the filing of its Form 10-K for the fiscal year ended March 31, 2024, and a subsequent press release regarding financial results.
📋 Key Facts
- Company filed its annual report (Form 10-K) for the fiscal year ending March 31, 2024.
- A conference call is scheduled for July 2, 2024, at 11:30 AM EDT to provide a business update and answer stockholder questions.
- The filing includes an exhibit (99.1) containing the press release with financial results.
Elite Pharmaceuticals, Inc. entered into an Asset Purchase Agreement with Nostrum Laboratories Inc. to acquire rights to three approved ANDAs and manufacturing technology.
📋 Key Facts
- Acquisition of ANDA rights for generic Norco (Hydrocodone/Acetaminophen), Percocet (Oxycodone/Acetaminophen), and Dolophine (Methadone).
- The transaction includes a royalty-free, non-exclusive perpetual license to manufacturing technology and proprietary processes.
- Total consideration is $900,000 in cash.
- Transaction closed on June 21, 2024.
Elite Pharmaceuticals Inc. announced a change in its independent registered public accounting firm due to a merger/transaction between Mazars USA LLP and Forvis, LLP. As a result of this transaction, Forvis Mazars, LLP will now serve as the Company's auditor effective June 1, 2024.
🚩 Red Flags
- None identified; the auditor change is a direct result of a firm merger rather than an internal dispute.
📋 Key Facts
- Mazars USA LLP effectively resigned due to a transaction with Forvis, LLP resulting in the formation of Forvis Mazars, LLP.
- Forvis Mazars, LLP is the successor auditor, recommended by the Audit Committee and approved by the Board.
- The change was effective June 1, 2024.
- The Company stated there were no disagreements with Mazars USA regarding accounting principles, financial statement disclosure, or auditing scope/procedures.
Elite Pharmaceuticals announced on May 20, 2024, that the FDA approved a generic version of Methotrexate Sodium 2.5 mg tablets to be sold under the Elite Laboratories, Inc. label.
📋 Key Facts
- FDA approval received on May 16, 2024.
- Product: Generic Methotrexate Sodium 2.5 mg tablets.
- Drug Class: Antimetabolites.
- Labeling: To be sold under the Elite Laboratories, Inc. label.
Elite Pharmaceuticals, Inc. filed an 8-K to announce the filing of its quarterly report on Form 10-Q for the period ended December 31, 2023, and a corresponding press release regarding financial results.
📋 Key Facts
- Filed Form 10-Q for the quarter ended December 31, 2023.
- Issued a press release announcing quarterly financial results on February 14, 2024.
- Scheduled a conference call and business update for February 15, 2024, at 11:30 AM EST.