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Hovione

Hovione is an international company with over 50 years’ experience in API development and compliant manufacture. With FDA inspected sites in the US, China, Ireland, and Portugal the company focuses on the most demanding customers, in the most regulated markets.

When you really care about quality and performance, Hovione is your API

The company offers integrated API, particle design and formulation development and manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.

From proof of concept studies to full commercialization

Hovione’s specialist capabilities in pharmaceutical fine chemicals have been enhanced through an extensive range of advanced and proven enabling technology platforms to address specific formulation and bioavailability issues. These particle design technologies include spray drying, spray congealing, hot melt extrusion, wet milling, fluidized spray drying and freeze drying and are further complemented by our ability to manufacture your API (including potent APIs) or to perform formulation studies for inhalation development using Hovione’s dry powder inhalers or other inhalers.

Spray drying facilities: the ability to not only control particle size, but also the morphology of the product

Our cGMP spray drying facilities give our customers the ability to not only control particle size, but also the morphology of the product, which allows for the optimization of the particle and delivery characteristics of preformulated APIs. Hovione can perform a wide range of feasibility studies, from just a few grams to full scale commercial production, to meet your specific product requirements.

Hovione International Presence

Our aim is to provide our customers with solutions for their complex drug delivery concerns.

Contact

Hovione
Sete Casas
2674 – 506 Loures
Portugal
Tel: +351 21 982 9000
Fax.+351 21 982 9388
Email: weblink@hovione.com
URL: www.hovione.com

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Generics

Generic APIs have been a core part of Hovione's business for the past 49 years. Over that time we launched more than 45 generic APIs to the most demanding customers in the United States, Europe and Japan and has gained a reputation in the Industry for superior quality, reliability and customer service.

Hovione has a track record for industrializing processes for molecules that few other companies can match. Our focus in developing and manufacturing difficult APIs has given us a deep understanding of the challenges and opportunities that exist in generic APIs.Hovione has over 90 DMFs filed worldwide and have been granted 10 CEPs. We assist our…

Inhalation

In order to help our customers solve complex problems throughout the years, we have invested in building know-how and expertise in particle design and formulation development for highly sophisticated inhalation APIs.

At Hovione we can tailor-make particle size ranges and incorporate desired morphology characteristics into your API. We are also able to start with a Hovione-produced API and develop a dry powder formulation to meet your inhalation product development demands.Dry Powder Inhaler Devices: Capsule-basedDry Powder Inhaler Devices: TwinCaps®Inhaled drug product development: The integrated approach at HovioneInhalation…

Exclusives

We provide the following exclusive products and services.

Multi-Scale cGMP ManufacturingKilo to ton quantities, including synthesis of 100s of gram quantities for pre-IND screening, cGMP production for phase I to phase III clinical studies, NDA validation batches and cGMP production for commercial quantities after NDA approvalMulti-scale manufacturing from oral to parenteral use, including sterile bulkMulti-scale manufacturing of regulated intermediates as well as APIsParticle…

Particle Design

Hovione’s specialist capabilities in pharmaceutical fine chemicals have been enhanced through an extensive range of advanced technologies to address specific Particle Design problems. Today, Hovione can carry out a wide range of Particle Design feasibility studies, from just a few grams to full scale commercial production, to meet your specific particle requirements.

Particle Design technologiesSpray dryingFluidized spray dryingSpray congealingHot melt extrusionMicronizationControlled crystallizationCocrystallizationJet millingFreeze dryingUltra sound assisted crystallizationMethodologies:BrittestQuality by DesignLean ManufacturingScale-up scienceProcess modelingProcess Analytical TechnologiesProducts:Solid dispersionsMicrocapsulesControlled released formulationsNanoparticlesCo-crystalsInhalation drugsDirect compressibles and dust free powders  
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