Rommelag CDMO GmbH

COMPANY PROFILE

Rommelag pioneered blow-fill-seal (BFS) technology and is the global leader in aseptic filling of liquids and semisolids using its bottelpack systems.

Description

Rommelag CDMO offers quick and easy access to contract filling with bottelpack BFS technology.

Even the highly compact bottelpack systems can’t fit in every company. And sometimes it’s simply a question of cost-effectiveness when the container quantities aren’t high enough or the packaging constantly changes. But none of this has to be an issue, because we blow-fill-seal for you.

Be it pharmaceuticals, medicine and cosmetics, or chemical products, we draw on our expertise and tailor our bottelpack systems specifically to your product. This is how we guarantee optimal sterile filling according to GMP guidelines for your liquid and semi-solid products. In addition, our Rommelag Pharma Service will work with you on a quick and economical complete concept for qualification and validation, which is recognized by the authorities.

Rommelag CDMO fills more than 2 million containers a day for customers all over the world. At Rommelag CDMO, we operate more than 50 systems in multiple configurations for you. And they are set up to meet stringent pharmaceutical standards, perform test fillings, and realize production batches or small-scale series for you. Giving you never-ending possibilities – without investing in your own system and infrastructure.

The pharma industry is without a doubt one of the primary users of the BFS process, but liquids and semi-solids are increasingly also ending up in BFS packaging in the chemical industry and in many other sectors.

Company (Headquarters):

Germany

Types of Drugs Manufactured:

Biologics; Medical Devices

CDMO Services:

Research & Development; Packaging(Commercial); Regulatory Services; Analytical Development;  Packaging(Clinical)

High Potent Products capabilities

OEB 3 Medium Potency

OEB 4-5 Highly Potent APIs (HPAPIs)

Therapeutic Area:

Ear, Nose, Throat and Oral Health; Ophthalmology; Respiratory; Diagnostics and Monitoring; Genito Urinary and Women's Health; Infectious Disease;  Medical Devices; Pain Symptoms; Wounds and Injuries; Endocrine and Hormonal

CDMO number of facilities:

2

Facilities Location:

Europe

Regulatory Approvals for facilities:

USA - FDA; Europe - EMA or constituent countries; GMP; ISO 9001; ISO 13485; Southkorea MFDS

Manufacturing Technologies:

Blow-Fill-Seal (BFS); sterile Ampoules

Certification
USA - FDA; Europe - EMA or constituent countries; GMP; ISO 9001; ISO 13485; Southkorea MFDS

Manufacturing Information

Facilities
2
Drug Type
Biologics, Medical Devices

Contact Information

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