Kamada Announces FDA Approval of its Plasma Collection Center in Houston, Texas
Kamada Ltd. (NASDAQ: KMDA) has received FDA approval for its plasma collection center in Houston, Texas, allowing commercial sales of normal source plasma. The 12,000 square foot facility features 50 donor beds with an annual collection capacity of 50,000 liters of plasma.
The Houston center, positioned to be one of the largest specialty plasma collection sites in the U.S., is expected to generate $8-10 million in annual revenue at full capacity. The facility will collect both normal source plasma and specialty plasma, including Anti-Rabies and Anti-D. This marks Kamada's third Texas-based site, alongside locations in San Antonio and Beaumont.
Kamada Ltd. (NASDAQ: KMDA) ha ottenuto l'approvazione della FDA per il suo centro di raccolta del plasma a Houston, Texas, che consente la vendita commerciale di plasma da fonte normale. Il centro di 12.000 piedi quadrati dispone di 50 lettini per donatori con una capacità annua di raccolta di 50.000 litri di plasma.
Il centro di Houston, destinato a diventare uno dei più grandi siti specializzati nella raccolta di plasma negli Stati Uniti, dovrebbe generare $8-10 milioni di entrate annue a piena capacità. La struttura raccoglierà sia plasma da fonte normale sia plasma speciali, inclusi Anti-Rabies e Anti-D. Questo rappresenta il terzo sito di Kamada in Texas, insieme alle sedi di San Antonio e Beaumont.
Kamada Ltd. (NASDAQ: KMDA) ha recibido la aprobación de la FDA para su centro de recogida de plasma en Houston, Texas, lo que permite la venta comercial de plasma de fuente normal. La instalación de 12.000 pies cuadrados cuenta con 50 camillas para donantes y una capacidad anual de recolección de 50.000 litros de plasma.
El centro de Houston, previsto para ser uno de los mayores sitios especializados en recolección de plasma en EE. UU., se espera que genere $8-10 millones en ingresos anuales a plena capacidad. La instalación recogerá tanto plasma de fuente normal como plasma especializados, incluidos Anti-Rabies y Anti-D. Este es el tercer sitio de Kamada en Texas, junto con las ubicaciones en San Antonio y Beaumont.
Kamada Ltd. (NASDAQ: KMDA)는 텍사스 휴스턴에 있는 플라즈마 채혈 센터에 대해 FDA의 승인을 받아 정상 출처 플라즈마의 상업적 판매가 허용되었습니다. 12,000 평방피트 규모의 시설에는 50개의 기증자 침대가 있으며 연간 50,000리터의 플라즈마를 수집할 수 있습니다.
휴스턴 센터는 미국에서 가장 큰 전문 플라즈마 채혈 사이트 중 하나가 될 것으로 예상되며, 최대 가동 시 연간 $8-10 million의 수익을 창출할 것으로 보입니다. 이 시설은 정상 출처 플라즈마와 Anti-Rabies 및 Anti-D를 포함한 특수 플라즈마를 모두 수집할 예정입니다. 이는 샌안토니오 및 보몬트의 지점과 함께 Kamada의 텍사스 내 세 번째 사이트입니다.
Kamada Ltd. (NASDAQ: KMDA) a obtenu l'autorisation de la FDA pour son centre de collecte de plasma à Houston, Texas, permettant la vente commerciale de plasma d'origine normale. L'installation de 12 000 pieds carrés comprend 50 lits pour donneurs et une capacité de collecte annuelle de 50 000 litres de plasma.
Le centre de Houston, destiné à devenir l'un des plus grands sites spécialisés de collecte de plasma aux États-Unis, devrait générer 8 à 10 millions de dollars de revenus annuels à pleine capacité. L'installation collectera à la fois du plasma d'origine normale et du plasma spécialisé, notamment Anti-Rabies et Anti-D. Il s'agit du troisième site de Kamada au Texas, aux côtés des implantations de San Antonio et Beaumont.
Kamada Ltd. (NASDAQ: KMDA) hat die FDA-Zulassung für sein Plasmasammelzentrum in Houston, Texas, erhalten, wodurch der kommerzielle Verkauf von normalem Spenderplasma erlaubt ist. Die 12.000 Quadratfuß große Anlage verfügt über 50 Spenderbetten und eine jährliche Sammelkapazität von 50.000 Litern Plasma.
Das Houston-Zentrum, das eines der größten spezialisierten Plasmasammelzentren in den USA werden soll, dürfte bei voller Auslastung $8–10 Millionen Jahresumsatz erzielen. Die Anlage wird sowohl normales Spenderplasma als auch Spezialplasma sammeln, darunter Anti-Rabies und Anti-D. Dies ist Kamadas dritter Standort in Texas, neben Niederlassungen in San Antonio und Beaumont.
- FDA approval enables immediate commercial sales of normal source plasma
- Significant capacity of 50,000 liters of plasma collection annually
- Expected annual revenue of $8-10 million at full capacity
- Strategic expansion with three Texas-based collection centers
- Capability to collect both normal source and high-value specialty plasma
- EMA approval still pending for the Houston facility
- Full revenue potential dependent on reaching maximum collection capacity
Insights
FDA approval of Kamada's Houston plasma center unlocks $8-10M annual revenue potential and strengthens specialty plasma collection capabilities.
The FDA approval of Kamada's Houston plasma collection center represents a significant operational milestone for the company's vertical integration strategy in the specialty plasma market. The 12,000 square foot facility with 50 donor beds has been designed to collect both normal source plasma and high-value specialty plasma products like Anti-Rabies and Anti-D immunoglobulins.
With an annual collection capacity of approximately 50,000 liters, this center is projected to generate between
The strategic importance of this approval extends beyond immediate revenue potential. By establishing what's anticipated to be one of the largest specialty plasma collection centers in the U.S., Kamada is securing a critical supply chain component for its plasma-derived therapeutics business. The company's focus on specialty plasma varieties (Anti-Rabies, Anti-D) targets higher-margin products compared to standard plasma, potentially improving overall profit margins.
The company's pursuit of subsequent EMA approval for this facility indicates plans to leverage these plasma resources for global markets. This multi-regulatory approach aligns with industry best practices for maximizing return on infrastructure investments while ensuring compliance with international standards for biological products.
- Houston Center Cleared to Commence Commercial Sales of Normal Source Plasma
- State of the Art Facility has Annual Collection Capacity of Approximately 50,000 Liters of Plasma and an Estimated Annual Revenue Contribution of
$8 Million to$10 Million at its Full Capacity - Center is Structured to Collect Normal Source Plasma and Specialty Plasma, such as Anti-Rabies and Anti-D; Anticipated to be One of the Largest Sites for Specialty Plasma Collection in the U.S.
REHOVOT, Israel, and HOBOKEN, N.J., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplement to its existing Biologics License Application (BLA) for Kamada Plasma’s collection center in Houston, TX. The approval was obtained following an on-site inspection made by the FDA during the second quarter of this year.
The center is now cleared to commence commercial sales of normal source plasma. The 12,000 square foot Houston facility supports 50 donor beds, with a planned capacity of approximately 50,000 liters per year, and is anticipated to be one of the largest collection centers for specialty plasma in the U.S.
“We are extremely pleased to announce the FDA approval of our state-of-the-art plasma collection center in Houston, and for the work of our dedicated team of plasma collection experts who achieved the approval of this facility,” said Amir London, Chief Executive Officer of Kamada. “Our three Texas-based sites, in Houston, San Antonio and Beaumont, provide us with significant capacity of specialty and normal source plasma collection.”
Following FDA’s approval of the Houston location, Kamada intends to seek a subsequent inspection and approval by the European Medicines Agency (EMA) of this site. In addition to its Houston and Beaumont, TX, locations, in March 2025, Kamada announced the opening of its third center in San Antonio, TX. Each of the Houston and San-Antonio centers are expected to generate annual revenues of
About Kamada
Kamada Ltd. (the “Company”) is a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived therapies field. The Company’s strategy is focused on driving profitable growth through four primary growth pillars: First, organic growth from its commercial activities, including continued investment in the commercialization and life cycle management of its proprietary products, which include six FDA-approved specialty plasma-derived products: KEDRAB®, CYTOGAM®, GLASSIA®, WINRHO SDF®, VARIZIG® and HEPAGAM B®, as well as KAMRAB®, KAMRHO (D)® and two types of equine-based anti-snake venom products, and the products in the distribution segment portfolio, mainly through the launch of several biosimilar products in Israel. Second: the Company aims to secure significant new business development, in-licensing, collaboration and/or merger and acquisition opportunities, which are anticipated to enhance the Company’s marketed products portfolio and leverage its financial strength and existing commercial infrastructure to drive long-term growth. Third: the Company is expanding its plasma collection operations to support revenue growth through the sale of normal source plasma to other plasma-derived manufacturers, and to support its increasing demand for hyper-immune plasma. The Company currently owns three operating plasma collection centers in the United States, in Beaumont Texas, Houston Texas, and San Antonio, Texas. Lastly, the Company is leveraging its manufacturing, research and development expertise to advance the development and commercialization of additional product candidates, targeting areas of significant unmet medical need, with the lead product candidate Inhaled AAT, for which the Company is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. FIMI Opportunity Funds, the leading private equity firm in Israel, is the Company’s controlling shareholder, beneficially owning approximately
Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding: 1) plasma collection center in Houston, TX has annual collection capacity of approximately 50,000 Liters of Plasma, 2) each of the Houston and San-Antonio centers expected to generate estimated annual revenue of
CONTACTS:
Chaime Orlev
Chief Financial Officer
IR@kamada.com
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578
britchie@LifeSciAdvisors.com
FAQ
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