Lallemand Pharma AG

About Lallemand Pharma

Lallemand Pharma AG, based in Massagno (Switzerland), is a subsidiary of the Canadian group Lallemand Inc., specializing in the development and marketing of products for respiratory health, with the status of medicines or medical devices. Since 2007, the company has distributed prescription medicines based on the bacterial lysate PMBL under the brands Ismigen, Immubron, Respibron, and PIR-05 for the prevention and treatment of recurrent respiratory infections in several countries. Starting in 2018, the company developed a nasal spray line called Healsea with the active ingredient Symbiofilm, an exopolymeric substance of maritime origin, which slows down the biofilm formation of respiratory pathogens and reduces the adhesion of respiratory viruses to the nasal mucosa. The sprays are offered as a Bag-on-Valve system or with manual pump spray technology. Additionally, Lallemand Pharma maintains dedicated departments for Regulatory Affairs, Pharmacovigilance, Supply and Customer Service, as well as Marketing, and invests in clinical research and scientific training. A European site of the group is located in Grenaa, Denmark.

Site

Massagno

Processes

Regulatory Affairs, Pharmacovigilance, Supply/Customer Service, Marketing, Research & Development (R&D), Clinical Research, Scientific Training for professionals and patients

Materials

PMBL (polyvalent bacterial lysate), Symbiofilm, Bag-on-Valve Technology

Certificates

MDR Certification (Regulation (EU) 2017/745) for pump spray product line with, MDR Certification Healsea BabyKids, Healsea Rescue and Healsea Dual, CE Marking Healsea Nasal Sprays (Bag-on-Valve and Pump Spray), MDR (Regulation (EU) 2017/745) – Pump Spray Product Line, MDR – Healsea BabyKids, Rescue and Dual, CE Marking Healsea (Bag-on-Valve and Pump Spray)

Industries

Pharmaceutical Industry, Medical Devices, Respiratory Health

1. 01

   Research & Development

2. 02

   Clinical Research and Regulatory Approval (Regulatory Affairs)

3. 03

   Production (Supplier/Partner Network)

4. 04

   Pharmacovigilance and Quality Management

5. 05

   Distribution via pharmaceutical partners globally

6. 06

   Marketing and scientific training

Active Ingredients and Technologies

Locations

Massagno

CH

Headquarters (Lallemand Pharma AG)

Materials

PMBL medicines, Healsea nasal sprays (Symbiofilm)

• Regulatory Affairs
• Pharmacovigilance
• Supply/Customer Service
• Marketing
• Research & Development

Grenaa

DK

Lallemand Pharma Europe

Products

Inside the production

Quality and Certification

The MDR certification according to Regulation (EU) 2017/745 validates the company's Quality Management System (QMS); the CE marking of the pump spray line and Healsea products confirms compliance with EU requirements for safety, performance, and clinical validation.

History

1. 2007

   Start of marketing of medicines with the bacterial lysate PMBL (Brands: Ismigen, Immubron, Respibron, PIR-05) – Rx products for the prevention and treatment of recurrent respiratory infections.

2. 2018

   Start of development of the Healsea nasal spray line with the active ingredient Symbiofilm.

3. 2021

   CE marking of both Healsea lines (Bag-on-Valve and manual pump spray) in April, enabling marketing throughout Europe.

4. 2024-12

   Elisa Cauli (QA & Technical Product Manager) represented Lallemand Pharma at the International Workshop on Extremophiles in Messina.

5. 2025-01

   Partnership between Lallemand Pharma and GM PHARMA for the launch of Healsea in Georgia.

6. 2025-03

   MDR certification of the pump spray product line achieved and indication expanded (Treatment of acute infectious rhinitis in children and adults).

7. 2026-07

   Healsea Dual receives MDR certification with dual indication: Prevention of respiratory infections and treatment of acute infectious rhinitis.