WuXi AppTec's Changzhou and Taixing API Sites Successfully Pass FDA Inspections
WuXi AppTec announced that its Active Pharmaceutical Ingredient (API) manufacturing sites in Changzhou and Taixing, China, have successfully passed U.S. FDA inspections in March 2025 with no observations or Form 483 issues.
The Changzhou facility's GMP surveillance inspection covered 21 FDA-approved products, while Taixing completed a Pre-Approval Inspection for commercial manufacturing of a peptide-based therapeutic. The 169-acre Taixing site, operational since September 2023, is the company's newest and largest API manufacturing facility.
WuXi AppTec is expanding globally with recent developments including:
- Doubled oral dose capacity at Couvet, Switzerland facility in 2024
- Ongoing construction of Middletown, Delaware site (operations expected by 2026)
- New Singapore R&D and manufacturing site groundbreaking (Phase I operations planned for 2027)
WuXi AppTec ha annunciato che i suoi siti di produzione di Ingredienti Farmaceutici Attivi (API) a Changzhou e Taixing, in Cina, hanno superato con successo le ispezioni della FDA degli Stati Uniti nel marzo 2025, senza osservazioni o problemi con il modulo 483.
L'ispezione di sorveglianza GMP della struttura di Changzhou ha coperto 21 prodotti approvati dalla FDA, mentre Taixing ha completato un'Ispezione Pre-Approva per la produzione commerciale di un terapeutico a base di peptide. Il sito di Taixing, che si estende su 169 acri e operativo da settembre 2023, 猫 il pi霉 recente e il pi霉 grande impianto di produzione di API dell'azienda.
WuXi AppTec sta espandendo la sua presenza globale con sviluppi recenti che includono:
- Capacit脿 di dosaggio orale raddoppiata presso l'impianto di Couvet, in Svizzera, nel 2024
- Costruzione in corso del sito di Middletown, Delaware (operazioni previste entro il 2026)
- Inizio dei lavori per un nuovo sito di R&S e produzione a Singapore (operazioni della Fase I previste per il 2027)
WuXi AppTec anunci贸 que sus sitios de fabricaci贸n de Ingredientes Farmac茅uticos Activos (API) en Changzhou y Taixing, China, han pasado con 茅xito las inspecciones de la FDA de EE. UU. en marzo de 2025, sin observaciones ni problemas con el Formulario 483.
La inspecci贸n de vigilancia GMP de la instalaci贸n de Changzhou cubri贸 21 productos aprobados por la FDA, mientras que Taixing complet贸 una Inspecci贸n Pre-Aprobaci贸n para la fabricaci贸n comercial de un terap茅utico basado en p茅ptidos. El sitio de Taixing, que abarca 169 acres y est谩 en operaci贸n desde septiembre de 2023, es la instalaci贸n de fabricaci贸n de API m谩s nueva y grande de la empresa.
WuXi AppTec est谩 expandi茅ndose globalmente con desarrollos recientes que incluyen:
- Capacidad de dosis oral duplicada en la instalaci贸n de Couvet, Suiza, en 2024
- Construcci贸n en curso del sitio de Middletown, Delaware (se espera que las operaciones comiencen en 2026)
- Inicio de la construcci贸n de un nuevo sitio de I+D y fabricaci贸n en Singapur (se prev茅 que las operaciones de la Fase I comiencen en 2027)
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WuXi AppTec a annonc茅 que ses sites de fabrication d'Ingr茅dients Pharmaceutiques Actifs (API) 脿 Changzhou et Taixing, en Chine, ont r茅ussi les inspections de la FDA am茅ricaine en mars 2025, sans observations ni probl猫mes avec le formulaire 483.
L'inspection de surveillance GMP de l'installation de Changzhou a couvert 21 produits approuv茅s par la FDA, tandis que Taixing a compl茅t茅 une Inspection Pr茅-Autorisation pour la fabrication commerciale d'un th茅rapeutique 脿 base de peptide. Le site de Taixing, s'茅tendant sur 169 acres et op茅rationnel depuis septembre 2023, est le plus r茅cent et le plus grand site de fabrication d'API de l'entreprise.
WuXi AppTec s'茅tend 脿 l'茅chelle mondiale avec des d茅veloppements r茅cents comprenant :
- Capacit茅 de dosage oral doubl茅e 脿 l'installation de Couvet, en Suisse, en 2024
- Construction en cours du site de Middletown, Delaware (les op茅rations devraient d茅buter en 2026)
- D茅but de la construction d'un nouveau site de R&D et de fabrication 脿 Singapour (les op茅rations de la phase I sont pr茅vues pour 2027)
WuXi AppTec gab bekannt, dass seine Produktionsst盲tten f眉r aktive pharmazeutische Inhaltsstoffe (API) in Changzhou und Taixing, China, im M盲rz 2025 erfolgreich die FDA-Inspektionen der USA bestanden haben, ohne Beobachtungen oder Probleme mit dem Formular 483.
Die GMP-脺berwachungsinspektion der Einrichtung in Changzhou umfasste 21 von der FDA genehmigte Produkte, w盲hrend Taixing eine Vorabgenehmigungsinspektion f眉r die kommerzielle Herstellung eines peptidbasierten Therapeutik abgeschlossen hat. Das 169 Hektar gro脽e Gel盲nde in Taixing, das seit September 2023 in Betrieb ist, ist die neueste und gr枚脽te API-Produktionsst盲tte des Unternehmens.
WuXi AppTec expandiert global mit aktuellen Entwicklungen, die Folgendes umfassen:
- Verdopplung der oralen Dosierungskapazit盲t in der Anlage in Couvet, Schweiz, im Jahr 2024
- Fortschreitender Bau des Standorts Middletown, Delaware (Betrieb wird f眉r 2026 erwartet)
- Baubeginn eines neuen Forschungs- und Entwicklungs- sowie Produktionsstandorts in Singapur (Betrieb der Phase I ist f眉r 2027 geplant)
- Successfully passed FDA inspections at two major API manufacturing sites with zero observations
- Operational approval for commercial manufacturing of peptide-based therapeutic at Taixing facility
- Significant global expansion with new facilities in Switzerland, USA, and Singapore
- Portfolio includes 21 FDA-approved products at Changzhou facility
- None.
The Company's API site at
On March 21, 2025, the API site at Taixing also completed a Pre-Approval Inspection (PAI) for the commercial manufacturing of a peptide-based therapeutic, with no observation. The site presented its state-of-the-art infrastructure, the team's strong technical expertise, and the high level of compliance demonstrated through its systems, documentation, and records. Operational since September 2023, the 169-acre Taixing site is the company's newest and largest API manufacturing facility. The successful inspection confirms the site's readiness to support commercial API supply to the global market.
"Our team's consistent focus on quality and compliance is key to enabling our global partners," said Dr. Minzhang Chen, Co-CEO of WuXi AppTec. "We're pleased that both the
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WuXi AppTec continues to invest in capacity expansion to meet growing global demand. The company's investment in its Couvet,
About WuXi AppTec
As a global company with operations across
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