Endo Receives U.S. FDA Approval of Manufacturing Facility in Indore, India
Endo (OTCQX: NDOI) has received FDA approval for commercial production of VASOSTRICT® at its new 20,000-square-foot aseptic manufacturing facility in Indore, India. This marks the facility's first FDA approval, expanding the company's sterile injectable production capacity.
The facility, specifically designed for aseptic manufacturing of sterile injectable products, will initially produce medicines in vials with future capabilities for syringe production. Production is estimated to begin in 2026, and Endo plans to seek additional product approvals for the site.
Endo (OTCQX: NDOI) ha ricevuto l'approvazione della FDA per la produzione commerciale di VASOSTRICT® presso il suo nuovo a Indore, India. Questo segna la prima approvazione della FDA per l'impianto, ampliando la capacità di produzione di prodotti iniettabili sterili dell'azienda.
L'impianto, progettato specificamente per la produzione asettica di prodotti iniettabili sterili, inizialmente produrrà medicinali in fiale con future capacità di produzione di siringhe. La produzione è stimata per iniziare nel 2026 e Endo prevede di richiedere ulteriori approvazioni per i prodotti presso il sito.
Endo (OTCQX: NDOI) ha recibido la aprobación de la FDA para la producción comercial de VASOSTRICT® en su nueva instalación de fabricación aséptica de 20,000 pies cuadrados en Indore, India. Esto marca la primera aprobación de la FDA para la instalación, ampliando la capacidad de producción de productos inyectables estériles de la empresa.
La instalación, diseñada específicamente para la fabricación aséptica de productos inyectables estériles, producirá inicialmente medicamentos en viales con futuras capacidades para la producción de jeringas. Se estima que la producción comenzará en 2026 y Endo planea buscar aprobaciones de productos adicionales para el sitio.
Endo (OTCQX: NDOI)는 인도 인도르에 있는 20,000 평방 피트의 무균 제조 시설에서 VASOSTRICT®의 상업 생산에 대한 FDA 승인을 받았습니다. 이는 이 시설의 첫 번째 FDA 승인으로, 회사의 무균 주사제 생산 능력을 확장하는 것입니다.
이 시설은 무균 주사 제품의 제조를 위해 특별히 설계되었으며, 처음에는 바이알에 약물을 생산하고 향후 주사기 생산을 위한 능력을 갖출 예정입니다. 생산은 2026년에 시작될 것으로 예상되며, Endo는 해당 사이트에 대한 추가 제품 승인을 요청할 계획입니다.
Endo (OTCQX: NDOI) a reçu l'approbation de la FDA pour la production commerciale de VASOSTRICT® dans sa nouvelle installation de fabrication aseptique de 20 000 pieds carrés à Indore, en Inde. Cela marque la première approbation de la FDA pour l'établissement, élargissant la capacité de production d'injectables stériles de l'entreprise.
L'établissement, conçu spécifiquement pour la fabrication aseptique de produits injectables stériles, produira initialement des médicaments en flacons avec de futures capacités pour la production de seringues. La production devrait commencer en 2026, et Endo prévoit de demander des approbations de produits supplémentaires pour ce site.
Endo (OTCQX: NDOI) hat die FDA-Zulassung für die kommerzielle Produktion von VASOSTRICT® in seiner neuen 20.000 Quadratfuß großen aseptischen Produktionsstätte in Indore, Indien, erhalten. Dies markiert die erste FDA-Zulassung für die Anlage und erweitert die sterile injizierbare Produktionskapazität des Unternehmens.
Die Anlage, die speziell für die aseptische Herstellung von sterilen Injektionsprodukten konzipiert wurde, wird zunächst Medikamente in Glasflaschen produzieren, mit zukünftigen Kapazitäten für die Produktion von Spritzen. Die Produktion wird voraussichtlich im 2026 beginnen, und Endo plant, zusätzliche Produktzulassungen für den Standort zu beantragen.
- FDA approval received for new manufacturing facility
- Increased production capacity for sterile injectables
- Facility capable of both vial and syringe production
- Strategic expansion of manufacturing capabilities
- Production not expected to begin until 2026
- Trading on OTCQX market rather than major exchange
- 20,000-square-foot site increases Endo's sterile injectable production capacity
- This marks the site's first
U.S. FDA approval - Endo is investing and innovating in its Injectable Solutions business
"This is a significant milestone for Endo as we invest and innovate in our sterile injectables business," said Scott Hirsch, Interim CEO of Endo. "The FDA approval of our newest manufacturing site demonstrates our commitment to meeting product demand and delivering quality medicines to patients."
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About Endo
Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at www.endo.com or connect with us on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements including, but not limited to, the statements by Mr. Hirsch and any statements relating to commercial production, product manufacturing, demand or delivery, regulatory approvals, future growth, investments or innovations, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, regulatory approvals and compliance, unexpected litigation or disputes, Endo's ability to successfully implement and execute on its strategies and initiatives, Endo's ability to successfully compete in the marketplace, and changes in competitive, market or regulatory conditions. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo's press releases and in its public filings with the
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SOURCE Endo, Inc.
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