Lukas Heil-Betriebsstätte

Lukas Heil-Betriebsstätte

LUKAS Heil-Betriebsstätte GmbH operates a high-performance production facility that complies with the latest GMP standards for sterile and aseptic liquids, particularly glass ampoules.

About the plant

Lukas Heil-Betriebsstätte GmbH specializes in contract manufacturing, contract filling, and packaging of aseptic and sterile pharmaceuticals, dietary supplements, and cosmetic active ingredients. Filling is carried out in ampoules and, upon request, in other containers.

The production facilities of LUKAS Heil-Betriebsstätte GmbH are equipped according to the latest pharmaceutical standards, including Class A/B cleanroom areas with all necessary facilities in accordance with the latest GMP (Good Manufacturing Practice) standards.

A visitor´s walkway surrounding the cleanroom, accessible at all times, allows potential contract customers to easily experience the high quality of the production facility and processes and conduct necessary audits.

As an independent Austrian company, we can respond competently, reliably, and flexibly to the demands and developments of our time, thus offering our customers a genuine alternative to globalized production.

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Certifications

• EMA (EU GMP)
• MFDS/KFDA (Republic of Korea GMP)

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Activity

• FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, BIOLOGICS, COSMETICS, NUTRACEUTICALS, SERVICES, OLIGONUCLEOTIDES, Skin products, Hair and scalp care products, Products for nails and cuticles, Oral hygiene products, Skin care, Other skin care products, Cream / paste, Liquid manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), 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)
• DEA: Schedule I (high potential for abuse / no medical use), Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL: 1
• Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients, (V01) Allergens
• Markets: EMA (EU), PMDA (Japan), MHRA (UK), MFDS (South Korea)

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Batch Size / Reactor

• Small, Medium

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics

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