Aenova Group - Location Münster, Germany

Aenova Group - Location Münster, Germany

Competence Center low-dosed high potent solids (hormones, hormone-like), low-dosed capsules.

About the plant

The Aenova site in Münster has special expertise in the development, production and packaging of low-dosed tablets and hard gelatine capsules containing highly potent APIs like hormones, hormone-related, corticoids, narcotics and other highly potent/low dosed APIs.

The site´s long tradition in the field of contraceptives and narcotics since 1966 is today accompanied by production technologies for micro-dosed capsules, e.g. dry powder inhalation capsules.

More information here: Aenova Group

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Certifications

• EMA (EU GMP)
• FDA (cGMP)
• ANVISA (Brazil B-GMP)
• Roszdravnadzor (Russia GMP)
• MFDS/KFDA (Republic of Korea GMP)
• TITCK (Turkish Health Authorities)

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Activity

• Inhalation products, Oral solids / OSD, Powder, Tablets, Hard capsules, Powders, FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, 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)
• DEA: N/A
• BSL:
• Therapeutic areas: (H) Systemic hormonal preparations excl. sex hormones and insulins
• Markets: FDA (USA), EMA (EU), ANVISA (Brazil), MFDS (South Korea), Russian Health Authorities, Turkish Health Authorities

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Batch Size / Reactor

• Small, Medium, Large

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Services

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

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