Ophtapharm, a Sentiss Company

Ophtapharm, a Sentiss Company

Ophtalmic and Otic - Solutions, suspensions, emulsions, ointments and gels - FDA Approved facility

About the plant

Specializing in sterile suspensions, solutions, emulsions, ointments and gels. Ophtapharm, a Sentiss Company, is a cutting-edge CDMO that exemplifies Swiss excellence in sterile pharmaceutical products for both human and veterinary use. Established in 1986, the facility is renowned for its unwavering commitment to quality, precision, and regulatory compliance. It combines Swiss quality with global regulatory approvals to uphold the highest standards of safety and efficacy, making it a trusted partner in the pharmaceutical industry for unparalleled expertise in sterile pharmaceutical manufacturing.

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• World Health Organization (GMP / HACCP)

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Activity

• Sterile forms (ophtalmic, nasal, otic), Terminal sterilization, Fill&Finish, Bottles, Dropper bottles, Tubes, 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):
• DEA: N/A
• BSL:
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU)

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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, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, Primary packaging, Secondary packaging, Labeling, Serialization

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