Elite Pharmaceuticals' Generic Adderall(R) Receives Marketing Approval from the Israeli Ministry of Health
Elite Pharmaceuticals (OTCQB: ELTP) has received approval from the Israeli Ministry of Health for its generic version of Adderall®. The product, an immediate-release mixed salt of amphetamine, will be available in 10 mg, 20 mg, and 30 mg tablets. Elite will supply the product to Dexcel Pharma, its exclusive distributor for the Israeli market.
The generic Adderall® is indicated for treating Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Under the agreement, Elite will manufacture and package the product under Dexcel's label, while Dexcel will handle sales, marketing, and distribution. Dexcel will pay an agreed transfer price and share profits under certain conditions. The product is jointly owned by Elite and Mikah Pharma .
The first shipment timeline depends on licensee orders, DEA quotas, and manufacturing processes, which could take months to complete.
Elite Pharmaceuticals (OTCQB: ELTP) ha ricevuto l'approvazione dal Ministero della Salute israeliano per la sua versione generica di Adderall®. Il prodotto, un sale misto di anfetamina a rilascio immediato, sarà disponibile in compresse da 10 mg, 20 mg e 30 mg. Elite fornirà il prodotto a Dexcel Pharma, il suo distributore esclusivo per il mercato israeliano.
Il generico Adderall® è indicato per il trattamento del Disturbo da Deficit di Attenzione/Iperattività (ADHD) e della Narcolessia. In base all'accordo, Elite produrrà e imballerà il prodotto sotto l'etichetta di Dexcel, mentre Dexcel si occuperà delle vendite, del marketing e della distribuzione. Dexcel pagherà un prezzo di trasferimento concordato e condividerà i profitti in determinate condizioni. Il prodotto è di proprietà congiunta di Elite e Mikah Pharma.
La tempistica della prima spedizione dipende dagli ordini dei licenziatari, dalle quote DEA e dai processi di produzione, che potrebbero richiedere mesi per essere completati.
Elite Pharmaceuticals (OTCQB: ELTP) ha recibido la aprobación del Ministerio de Salud israelí para su versión genérica de Adderall®. El producto, una sal mixta de anfetamina de liberación inmediata, estará disponible en tabletas de 10 mg, 20 mg y 30 mg. Elite suministrará el producto a Dexcel Pharma, su distribuidor exclusivo para el mercado israelí.
El Adderall® genérico está indicado para el tratamiento del Trastorno por Déficit de Atención e Hiperactividad (TDAH) y la Narcolepsia. Según el acuerdo, Elite fabricará y empaquetará el producto bajo la etiqueta de Dexcel, mientras que Dexcel manejará las ventas, el marketing y la distribución. Dexcel pagará un precio de transferencia acordado y compartirá las ganancias bajo ciertas condiciones. El producto es de propiedad conjunta entre Elite y Mikah Pharma.
La cronología del primer envío depende de los pedidos de los licenciatarios, las cuotas de la DEA y los procesos de fabricación, que podrían llevar meses en completarse.
엘리트 제약(OTCQB: ELTP)이 이스라엘 보건부로부터 애더럴®의 제네릭 버전에 대한 승인을 받았습니다. 이 제품은 즉각 방출 혼합 산의 정제로 10mg, 20mg 및 30mg로 제공됩니다. 엘리트는 이스라엘 시장을 위한 독점 유통업체인 Dexcel Pharma에 제품을 공급할 것입니다.
제네릭 애더럴®은 주의력 결핍 과잉행동 장애(ADHD) 및 기면증 치료에 적합합니다. 계약에 따라 엘리트는 Dexcel의 브랜드로 제품을 제조하고 포장하며, Dexcel은 판매, 마케팅 및 유통을 담당합니다. Dexcel은 합의된 전환 가격을 지불하고 특정 조건 하에 이익을 공유할 것입니다. 이 제품은 엘리트와 Mikah Pharma의 공동 소유입니다.
첫 번째 배송 일정은 라이센스 주문, DEA 할당량 및 제조 공정에 따라 달라지며, 전체 과정은 몇 달이 걸릴 수 있습니다.
Elite Pharmaceuticals (OTCQB: ELTP) a reçu l'approbation du ministère israélien de la Santé pour sa version générique d'Adderall®. Le produit, un sel mixte d'amphétamine à libération immédiate, sera disponible en comprimés de 10 mg, 20 mg et 30 mg. Elite fournira le produit à Dexcel Pharma, son distributeur exclusif pour le marché israélien.
L'Adderall® générique est indiqué pour le traitement du trouble déficitaire de l’attention avec hyperactivité (TDAH) et de la narcolepsie. Selon l'accord, Elite fabriquera et conditionnera le produit sous l'étiquette de Dexcel, tandis que Dexcel s'occupera des ventes, du marketing et de la distribution. Dexcel paiera un prix de transfert convenu et partagera les bénéfices sous certaines conditions. Le produit appartient conjointement à Elite et à Mikah Pharma.
Le calendrier du premier envoi dépend des commandes des licenciés, des quotas de la DEA et des processus de fabrication, qui pourraient prendre des mois à compléter.
Elite Pharmaceuticals (OTCQB: ELTP) hat die Genehmigung des israelischen Gesundheitsministeriums für seine generische Version von Adderall® erhalten. Das Produkt, ein sofort freisetzendes gemischtes Salz von Amphetamin, wird in Tabletten zu 10 mg, 20 mg und 30 mg erhältlich sein. Elite wird das Produkt an Dexcel Pharma liefern, seinen exklusiven Distributor für den israelischen Markt.
Das generische Adderall® ist zur Behandlung von Aufmerksamkeitsdefizit-Hyperaktivitätsstörung (ADHS) und Narkolepsie angezeigt. Im Rahmen der Vereinbarung wird Elite das Produkt unter dem Label von Dexcel herstellen und verpacken, während Dexcel den Verkauf, das Marketing und die Distribution übernimmt. Dexcel wird einen vereinbarten Transferpreis zahlen und unter bestimmten Bedingungen Gewinne teilen. Das Produkt gehört gemeinsam Elite und Mikah Pharma.
Der Zeitrahmen für die erste Lieferung hängt von den Bestellungen der Lizenznehmer, den DEA-Quoten und den Herstellungsprozessen ab, die mehrere Monate in Anspruch nehmen könnten.
- Received marketing approval for generic Adderall® from Israeli Ministry of Health
- Exclusive distribution agreement with Dexcel Pharma for the Israeli market
- Potential for profit sharing with Dexcel under certain conditions
- First shipment timeline uncertain, dependent on various factors including DEA quotas
- Product jointly owned with Mikah Pharma , potentially affecting profit margins
Northvale, New Jersey--(Newsfile Corp. - October 10, 2024) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company developing niche generic products, today 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. 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 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.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops, manufactures, and distributes niche generic products. Elite's product lines consist of immediate-release and controlled-release, solid oral dose products, which are marketed under the Elite Laboratories label, as well as pursuant to licenses granted to third-party pharmaceutical marketing and distribution organizations. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. For more information, visit www.elitepharma.com.
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
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/226314
FAQ
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