Skyepharma

Skyepharma

EXPERT AND INNOVATIVE CDMO COMPLEX ORAL SOLIDS: Fully integrated french CDMO Skyepharma is a key player in drug development and delivery of oral technologies serving the global pharmaceutical, biotech and consumer health industries.

About the plant

 

Know More: https://www.skyepharma.com/

---

Certifications

• EMA (EU GMP)
• FDA (cGMP)
• World Health Organization (GMP / HACCP)
• ANVISA (Brazil B-GMP)

---

Activity

• Oral solids / OSD, Tablets, Hard capsules, SoftGel capsules, Granules / Pellets, Powders, Lyophilizates, Lozenges, Gummies, FDF / DRUG PRODUCTS manufacturing

---

Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
• Toxicity (OEB classification):
• DEA: N/A
• BSL:
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU), ANVISA (Brazil)

---

Batch Size / Reactor

• Small, Medium, Large

---

Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP

---