Piramal Pharma Solutions and NewAmsterdam Pharma Invest in Dedicated Suite to Enhance Oral Solid Dosage Production Capabilities at Piramal's Sellersville, Pennsylvania Site
NewAmsterdam Pharma (NASDAQ:NAMS) and Piramal Pharma Solutions announced the opening of a dedicated oral solid dosage (OSD) manufacturing suite at Piramal's Sellersville, Pennsylvania facility. The multi-million-dollar investment aims to enhance production capabilities for NewAmsterdam's fixed dose combination (FDC) of obicetrapib and ezetimibe, a non-statin cholesterol medication.
The new suite features advanced capabilities for granulation, compression, tableting, and coating, specifically designed for multi-layer tablet production. The collaboration extends beyond Sellersville, with support from Piramal's facilities in Ahmedabad and Pithampur, India. The investment is expected to create over 20 new jobs at the Sellersville site over the next five years.
NewAmsterdam Pharma (NASDAQ:NAMS) e Piramal Pharma Solutions hanno inaugurato una linea dedicata alla produzione di forme solide orali (OSD) presso lo stabilimento Piramal di Sellersville, Pennsylvania. L'investimento multimilionario mira a potenziare la capacit脿 produttiva della combinazione a dose fissa (FDC) di obicetrapib ed ezetimibe, un farmaco per il colesterolo non appartenente alla classe delle statine.
La nuova linea 猫 dotata di tecnologie avanzate per granulazione, compressione, pressatura e rivestimento, progettate specificamente per la produzione di compresse multistrato. La collaborazione si estende oltre Sellersville, con il supporto degli stabilimenti Piramal di Ahmedabad e Pithampur, in India. L'investimento dovrebbe creare oltre 20 nuovi posti di lavoro nello stabilimento di Sellersville nei prossimi cinque anni.
NewAmsterdam Pharma (NASDAQ:NAMS) y Piramal Pharma Solutions anunciaron la apertura de una l铆nea dedicada a la fabricaci贸n de formas s贸lidas orales (OSD) en la instalaci贸n de Piramal en Sellersville, Pensilvania. La inversi贸n multimillonaria tiene como objetivo aumentar la capacidad de producci贸n de la combinaci贸n de dosis fija (FDC) de obicetrapib y ezetimiba, un medicamento para el colesterol que no es una estatina.
La nueva sala cuenta con capacidades avanzadas para granulaci贸n, compresi贸n, tableteado y recubrimiento, dise帽adas espec铆ficamente para la producci贸n de tabletas multicapa. La colaboraci贸n se extiende m谩s all谩 de Sellersville, con apoyo de las instalaciones de Piramal en Ahmedabad y Pithampur, India. Se espera que la inversi贸n genere m谩s de 20 nuevos empleos en el sitio de Sellersville durante los pr贸ximos cinco a帽os.
NewAmsterdam Pharma (NASDAQ:NAMS)鞕� Piramal Pharma Solutions電� 韼滌嫟氩犾澊雼堨晞欤� 靺�霟姢牍岇棎 鞙勳箻頃� Piramal 鞁滌劋鞐� 瓴疥惮鞖� 瓿犿槙鞝�(OSD) 鞝勳毄 鞝滌“ 霛检澑鞚� 臧滌劋頄堧嫟瓿� 氚滍憸頄堨姷雼堧嫟. 鞚� 靾橂氨毵� 雼煬 攴滊鞚� 韴瀽電� 牍勳姢韮�韹� 瓿勳棿鞚� 旖滊爤鞀ろ厡搿� 鞎诫鞚� 鞓る箘靹疙姼霛茧瓿� 鞐愳牅韹半敫岇潣 瓿犾爼鞖╇焿氤戩毄鞝�(FDC) 靸濎偘 電ル牓鞚� 臧曧檾頃橂姅 瓴冹潉 氇╉憸搿� 頃╇媹雼�.
靸� 霛检澑鞚� 瓿茧頇�, 鞎曥稌, 鞝曥牅, 旖旐寘鞚� 鞙勴暅 觳嫧 靹る箘毳� 臧栰稊瓿� 鞛堨溂氅�, 雼れ傅 鞝曥牅 靸濎偘鞐� 毵烄栋 靹り硠霅橃棃鞀惦媹雼�. 鞚� 順戨牓鞚� 靺�霟姢牍岇潉 雱橃柎 鞚鸽弰 Ahmedabad鞕� Pithampur鞚� Piramal 鞁滌劋鞚� 歆�鞗愳溂搿� 頇曤寑霅╇媹雼�. 頃措嫻 韴瀽電� 頄ロ泟 5雲� 雮挫棎 靺�霟姢牍� 順勳灔鞐� 20氇� 鞚挫儊鞚� 鞁犼窚 瓿犾毄鞚� 彀届稖頃� 瓴冹溂搿� 鞓堨儊霅╇媹雼�.
NewAmsterdam Pharma (NASDAQ:NAMS) et Piramal Pharma Solutions ont annonc茅 l'ouverture d'une suite d茅di茅e 脿 la fabrication de formes orales solides (OSD) sur le site de Piramal 脿 Sellersville, Pennsylvanie. L'investissement de plusieurs millions de dollars vise 脿 renforcer les capacit茅s de production de la combinaison 脿 dose fixe (FDC) d'obicetrapib et d'茅z茅timibe, un m茅dicament contre le cholest茅rol non statine.
La nouvelle suite dispose de capacit茅s avanc茅es de granulation, compression, mise en comprim茅 et enrobage, con莽ues sp茅cifiquement pour la production de comprim茅s multi鈥慶ouches. La collaboration s'茅tend au鈥慸el脿 de Sellersville, avec le soutien des sites Piramal d'Ahmedabad et de Pithampur en Inde. L'investissement devrait permettre de cr茅er plus de 20 nouveaux emplois sur le site de Sellersville au cours des cinq prochaines ann茅es.
NewAmsterdam Pharma (NASDAQ:NAMS) und Piramal Pharma Solutions haben die Er枚ffnung einer speziellen Produktionslinie f眉r orale Feststoffformen (OSD) in der Piramal-Anlage in Sellersville, Pennsylvania, bekannt gegeben. Die mehrmillionenschwere Investition zielt darauf ab, die Produktionskapazit盲ten f眉r NewAms festen Kombinationstanz (FDC) aus Obicetrapib und Ezetimib, einem nicht-statinbasierten Cholesterinmedikament, zu erweitern.
Die neue Anlage verf眉gt 眉ber fortschrittliche Kapazit盲ten f眉r Granulation, Kompression, Tablettierung und Beschichtung und ist speziell f眉r die Herstellung von Mehrschichttabletten ausgelegt. Die Zusammenarbeit geht 眉ber Sellersville hinaus und wird von Piramals Standorten in Ahmedabad und Pithampur, Indien, unterst眉tzt. Es wird erwartet, dass die Investition in den n盲chsten f眉nf Jahren mehr als 20 neue Arbeitspl盲tze am Standort Sellersville schafft.
- Creation of over 20 new jobs at the Sellersville site over next 5 years
- Multi-million dollar investment enhancing manufacturing capabilities
- Strategic partnership across multiple facilities demonstrating operational efficiency
- Increased production capacity to meet potential high commercial demand
- None.
Insights
Piramal and NewAmsterdam's multi-million dollar manufacturing investment strengthens production capacity for potential blockbuster cholesterol medication.
This partnership represents a significant manufacturing capacity expansion with strategic implications for both companies. The dedicated oral solid dosage (OSD) suite at Piramal's Sellersville facility demonstrates strong confidence in NewAmsterdam's fixed dose combination (FDC) of obicetrapib and ezetimibe, a non-statin cholesterol medication targeting LDL-C reduction. The multi-million dollar investment signals expectations of substantial commercial demand if regulatory approval is secured.
The manufacturing suite's specialized capabilities for multi-layer tablet production鈥攊ncluding advanced granulation, compression, tableting, and coating technologies鈥攔eflects the technical complexity of the FDC formulation. Particularly noteworthy is Piramal's integrated development approach, leveraging multiple facilities: development work at Ahmedabad and dual-sourcing support from Pithampur provide crucial redundancy for supply chain resilience.
From an operational perspective, the creation of 20+ new manufacturing jobs over five years indicates meaningful production volume expectations. The dedicated suite model offers significant advantages over shared manufacturing space, including enhanced quality control, contamination prevention, and scheduling flexibility鈥攁ll critical factors for high-volume pharmaceutical manufacturing.
This expansion demonstrates the continued evolution of the CDMO business model, where contract manufacturers make substantial capital investments based on the commercial potential of specific client products. For NewAmsterdam, securing dedicated manufacturing capacity represents a strategic advantage by ensuring production scalability for their lead asset without building internal manufacturing infrastructure.
- The multi-million-dollar investment provides NewAmsterdam Pharma with commercial capacity for fixed dose combination (FDC) of obicetrapib and ezetimibe to meet potentially high commercial demand.
- Piramal Pharma Solutions harnessed the strength of two additional facilities to efficiently produce the FDC, demonstrating the advantages of its integrated approach to development.
The suite represents a multi-million-dollar investment in equipment upgrades and enhancements to improve the site's capabilities. This includes a reconfiguration of existing space to create a dedicated OSD suite that will be used exclusively for fixed dose combination products. The new suite is designed for turnkey, multi-layer tablet production, equipped with advanced capabilities and technology to support granulation, compression, tableting, and coating.
This suite will facilitate the production of NewAmsterdam Pharma's investigational FDC, a non-statin cholesterol medication to reduce LDL-C.听
Although the suite is essential to the FDC's production, the partnership between Piramal Pharma Solutions and NewAmsterdam Pharma extends beyond the
"We are thrilled to expand our OSD production capabilities at the
"By investing in Piramal Pharma Solutions'
Patients aren't the only beneficiaries of this investment. Over the next five years, the suite is expected to create more than 20 new jobs at the
This investment underscores the commitment to continuous improvement shared by Piramal Pharma Solutions and NewAmsterdam Pharma. By adding the new production suite, both companies can operate with greater efficiency and capacity, ultimately bringing the FDC product, if approved, to more patients in need.听
About Obicetrapib
Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company's Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company's Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in
About NewAmsterdam
NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage clinical biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. The Company seeks to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple Phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.
About Piramal Pharma Solutions
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in
For more information visit: 听触 触听听触
About Piramal Pharma Limited
Piramal Pharma Limited (PPL, NSE: PPLPHARMA I BSE: 543635), offers a portfolio of differentiated products and services through its 17* global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated contract development and manufacturing organization; Piramal Critical Care (PCC), a complex hospital generics business; and the Piramal Consumer Healthcare business, selling over-the-counter consumer and wellness products. In addition, one of PPL's associate companies, Abbvie Therapeutics India Private Limited, a joint venture between Abbvie and PPL, has emerged as one of the market leaders in the ophthalmology therapy area in the Indian pharma market. Further, PPL has a strategic minority investment in Yapan Bio Private Limited, that operates in the biologics / bio-therapeutics and vaccine segments.
For more information, visit:听 |
* Includes one facility via PPL's minority investment in Yapan Bio.
Photo :听https://mma.prnewswire.com/media/2755167/Peter_DeYoung.jpg
Photo : https://mma.prnewswire.com/media/2755168/Douglas_Kling.jpg
Photo : https://mma.prnewswire.com/media/2755169/Group_Photo.jpg
Logo :听https://mma.prnewswire.com/media/2755170/NewAmsterdam_Logo.jpg
Logo :
听
View original content to download multimedia:
SOURCE Piramal Pharma Solutions
FAQ
What is the purpose of NewAmsterdam Pharma's investment in Piramal's Sellersville facility?
How many jobs will the new NAMS manufacturing suite create at Piramal's Sellersville facility?
Which Piramal facilities are involved in NewAmsterdam Pharma's FDC production?
What capabilities does the new NAMS manufacturing suite at Piramal Sellersville include?
