Micro-Sphere SA Farma Industria Ticino

Micro-Sphere SA

Address

Via Cantonale 77
6998 Monteggio

Phone

+41 58 776 70 00

Links

www.microsphere.ch/
[email protected]

Social

Microsphere SA is a Swiss-based pharmaceutical CDMO specializing in spray drying, capsule filling, and R&D.

With over 27 years of experience and more than 500 APIs and drug products handled, the company supports its clients throughout the entire product lifecycle, from early development activities to commercial-scale GMP manufacturing.

Microsphere operates in accordance with cGMP standards and complies with the requirements of major international regulatory authorities—including Swissmedic, the PMDA, and the US FDA—boasting a 100% success rate in regulatory approvals.

Microsphere possesses extensive experience in handling Highly Potent Active Pharmaceutical Ingredients (HPAPIs), with specific expertise in the development of dry powders for inhalation (DPIs) and the formulation of hydrophobic molecules using nanoemulsions.

While its core business lies in pharmaceutical CDMO activities, Microsphere also possesses development expertise in the cosmetic, nutraceutical, and natural product sectors, as well as in medical devices.

Furthermore, Microsphere has developed Lacto-Sphere®, a proprietary line based on US-sourced, BSE/TSE-free lactose monohydrate, specifically designed for formulations intended for inhalation administration. It is available in two variants:

Lacto-Sphere® MM3, with a mean particle size of 3 μm;
Lacto-Sphere® MM50, with a mean particle size of 50 μm.

Activities

Main Activity

Development
Co-development
Drug Product CMO
Drug Substance CMO
Drug development
Drug commercialization (Partial)
API Manufacturing (Partial)
Extracts
Analytical Services
Micronization
Pre-formulation
Spray-Drying
Other Activities

Therapeutic Areas

Cancer supportive therapy
Cardiology
CNS
Dermatology
Endocrinology/Diabetes
Gastrointestinal
Gynaecology/Women's Health
Infertility
Infectious diseases
Anesthesia
Mental health
Metabolism
Oncology
Ophthalmology
Orthopedics
Pain
Respiratory
Rheumatology
Urology
Other therapeutic areas

Markets

CH
EU Top 5
Rest of Europe
USA and Canada
Japan
LATAM
MENA
BRICS
ASEAN
Australia
Other market

Drug Stages

Pre-clinical
Clinical Phase I/Phase III
Phase I - Phase III
Registration
Market
Generic Plus (505B2)
Generic
Life cycle management

Drug Product Forms

Inhaler
Injectable (Partial)
Oral (solid)
Oral (liquid)
Spray (Partial)
Other drug form

Certifications

Swissmedic
FDA
European Medicines Agency
GMP
PMDA

ESG Certifications & Collaborations

AEnEC/EmAW
Other