ËÄÉ«AV

ËÄÉ«AV Loures has been operational since 1969. The site has grown continually as upgraded facilities have been added. The plant was first approved by the FDA in 1982, and is regularly inspected.

The site has an extensive capacity for drug substance manufacturing and particle engineering. ËÄÉ«AV Loures can support the development, piloting and full commercialization of your drug substance and drug product intermediate based on an available capacity of 430 cubic meters of vessels, ranging from 50 to 14,000lt, complemented with a full range of spray dryers, from lab scale to industrial sizes.

The site houses a large and well qualified Process Development and Analytical Development team in the areas of Drug Substance, Particle Engineering and Drug Product.

Areas of Focused Expertise

The site hasÌýworldÌýclassÌýcapabilities and physical assets in the following areas:

• Highly Potent API Handling (down to 0.03µ³¾/m³)
• Cryogenic (Volume 2000L to 5000L, Temperature Range -120 to 200ºC)
• Hydrogenation (Volume 100L to 5000L, Pressure Rating 10 to 100bar)
• Corticosteroids (Volume 50L to 8000L in two dedicated buildings)
• Spray drying (Lab Scale, PSD1 to PSD4)
• Potent spray drying (PSD3)

For details about production equipment –Ìýclick here

Operations

• The Loures plant operates 24 hours a day 7 days a week.
• Quality Control labs supportÌýproduction 24 hours a day 7 days a week.
• Plant maintenance shutdown period takes place forÌý3 weeks in August.

Certifications

The site has an Health, Safety and Environment Management System in accordance with OHSAS18001 and ISO14001. The system is periodically audited and reviewed and is ISO14001 and OHSAS18001 certified.

TheÌýsiteÌýis a certified Authorized Economic Operator.

ËÄÉ«AV Farmaciência S.A. is a member of the BCSD PortugalÌýwhich reflects our commitment to work for a more sustainable business.

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