Aenova Group - Location Carugate, Italy

Aenova Group - Location Carugate, Italy

Competence Center Semisolids and non-sterile liquids.

About the plant

Thi site has been producing and packaging semisolids for pharmaceuticals, medical devices and cosmetics as well as non-sterile liquids.

These include creams and gels, rectal and ovarian suppositories. The site can produce both human and veterinary products.

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Compliance

• ISO
• EMA (EU GMP)
• Roszdravnadzor (Russia GMP)
• SFDA (Saudi Food & Drug Authority)
• 9001
• 13485 (Medical devices)
• 14001
• 45001

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Activity

• Oral liquids and semisolids, Topical, mucosal and transdermal, Semisolid forms, Rectal and vaginal dosage forms, FDF / DRUG PRODUCTS, COSMETICS, Cream / paste, Liquid, Spray, Others, Foam manufacturing

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Features

• Uses: Human, Veterinary
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
• Controlled substance: N/A
• BSL: N/A
• Therapeutic areas: N/A
• Markets: EMA (EU), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia)

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Primary packaging, Secondary packaging, Labeling, Serialization

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