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Elite Pharmaceuticals, Inc. Issues Statement on Product Approval Listing

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Elite Pharmaceuticals, Inc. (OTCQB:ELTP) addressed inquiries about a recent ANDA approval listing for nifedipine, clarifying that this approval is not related to any product developed by the company. Nifedipine is not part of Elite's pipeline, which is detailed in their government filings and public communications. Elite's commercial products are registered under their subsidiary, Elite Laboratories, Inc. The company focuses on developing niche generic products and operates a registered facility for research and manufacturing in Northvale, NJ.

Positive
  • Specializes in niche generic products, enhancing market position.
  • Operates a cGMP and DEA registered facility, ensuring compliance and quality.
Negative
  • ANDA approval listed does not pertain to any of Elite's pipeline products, potentially causing investor confusion.
  • Lack of new product development announcements may signal stagnant growth.

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NORTHVALE, NJ / ACCESSWIRE / November 24, 2020 / Elite Pharmaceuticals, Inc. (“Elite” or the “Company”) (OTCQB:ELTP) received inquiries about a recent ANDA approval listing for nifedipine under the company name of Elite Pharma. This ANDA approval is not a product developed by Elite. Elite's pipeline has been disclosed in our government filings, our website, or our quarterly conference calls and nifedipine is not one of our projects. Elite's commercial products are registered with the FDA under Elite Laboratories, Inc., a wholly-owned subsidiary of Elite Pharmaceuticals.

About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company which develops niche generic products. Elite specializes in developing and manufacturing oral, controlled-release drug products. Elite owns multiple generic products which have been licensed to Lannett Company, Glenmark Pharmaceuticals, Inc., and TAGI Pharma. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release. Readers are cautioned that such forward-looking statements involve, without limitation, risks, uncertainties and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of products by the FDA, and the actions the FDA may require of Elite in order to obtain such approvals. These forward-looking statements are not guarantees of future action or performance. These risks and other factors are discussed, without limitation, in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q, and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com
www.elitepharma.com

SOURCE: Elite Pharmaceuticals, Inc.



View source version on accesswire.com:
https://www.accesswire.com/618092/Elite-Pharmaceuticals-Inc-Issues-Statement-on-Product-Approval-Listing

FAQ

What does the recent ANDA approval listing mean for Elite Pharmaceuticals (ELTP)?

The ANDA approval listing for nifedipine does not relate to any products developed by Elite Pharmaceuticals.

Is nifedipine part of Elite Pharmaceuticals' product pipeline?

No, nifedipine is not included in Elite's disclosed product pipeline.

What is Elite Pharmaceuticals' focus in drug development?

Elite Pharmaceuticals specializes in developing niche generic products and controlled-release drug products.

Where is Elite Pharmaceuticals' manufacturing facility located?

Elite operates a cGMP and DEA registered facility in Northvale, NJ.

Are there any risks associated with Elite Pharmaceuticals' future product approvals?

Yes, there are risks and uncertainties that may affect future product approvals by the FDA.
Elite Pharmaceuticals Inc

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