Machine BFS

CDMO: industrial expertise for your commercial batches

At Unither Pharmaceuticals, we support pharmaceutical laboratories in the commercial production of liquid solutions or suspensions for technical and demanding dosage formats: sterile BFS unit doses, liquid stick packs, standard or multi-dose vials, and sprays.

With over 30 years of experience, we are a leading CDMO in high-capacity manufacturing, compliant with cGMP, EMA, and FDA standards, and multi-regional regulatory requirements.

Our 8 sites located in France, the United States, Brazil, and China provide us with global coverage, enabling the industrialization and production of your products on an international scale.

Capacities tailored to your ambitions

Our technologies are developed for industrial production, ensuring high reproducibility and demonstrated procedural robustness, in compliance with GMP standards.

The manufactured products cover a wide range of applications: oral health, cold and flu remedies, gastroenterology, ophthalmology, pain management, respiratory diseases, rhinology, gynecology, and wound care.

Each year we produce:

5 billion

BFS units - world leader

500 million

liquid stick packs

Millions

of vials and sprays

Quality, reliability, and regulatory compliance

Blow-Fill-Seal unit doses

Our sites are certified by the main authorities:

  • Europe: ISO 13485, cGMP EU, EMA EU, ANSM France, GMED, DM France, ANSES France, MHRA UK, UL Underwriters Laboratories
  • North America: USFDA, cGMP US Drug Enforcement Agency, Canadian Health, UL Underwriters Laboratories
  • South America: cGMP ANVISA Brazil, INVIMA Colombia, MHA Mexico
  • Asia: DRAP Pakistan, MFDS Korean, TGA Australia, Turkish Ministry of Health
  • China: GMP China
  • Africa & Middle East: GCCDR Gulf Central, SFDA Saudi Arabia, IFDA Iran, LMRA Libya

Each batch is manufactured using validated, industrialized, and reproducible processes to ensure consistent quality, even at very high volumes.
We also support your industrial transfers post-MA or from another manufacturing site, ensuring traceability and regulatory compliance.

A global production infrastructure

Our high-capacity sites are located on four continents and offer you:

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Secure industrial continuity

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Inter-site backup options

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Controlled schedules

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Broad international regulatory coverage

Overview

Why choose Unither Pharmaceuticals sites to manufacture your products?

8 high-capacity production sites, spread across 4 continents

International coverage with delivery to over 100 countries, with adapted packaging and paperwork

Recognized expertise in technologies such as BFS, Liquid Stick Packs, and Sprays

High capacity and backup sites available

FAQ - large-scale commercial batch manufacturing

Yes. Each site has its own laboratory to ensure formulations are suitable for industrial capacities, to facilitate adaptations, and to optimize processes directly linked to production.

We primarily offer BFS (Blow-Fill-Seal), liquid stick packs, sprays, and multi-dose vials.

Absolutely. Our teams are experienced in industrial transfer and scale-up, whether from other CDMOs, client sites, or post-development. The process is structured, documented, and safe.

Yes. We regularly manage multi-regional production campaigns, adapting packaging and regulatory files to meet local requirements.