Contract Manufacturing

Contract Manufacturing

Medochemie is a customer focused CMO, headquartered in Europe with a legacy of 40 years of technology expertise.

Building on our experience, we are a reliable partner to deliver flexible solutions, from purchasing of API and materials to production, packaging, QC testing of finish products and Regulatory support.

We offer services covering most pharmaceutical dose forms, while providing significant capacity in Liquids, Ointments and Creams.

Our organization is focused on developing in our people, equipment’s and processes in order to deliver excellent CMO services for our customers.

We want to be a partner of choice, recognized for our customer focus and high-quality finished products.
 

Manufacturing sites involved in contract manufacturing:

Medochemie has in total 13 EU GMP manufacturing sites. However, 4 manufacturing sites are offering capacity for CMO services. All sites are operating in full compliance with current regulations for Good Manufacturing Practice (GMP) of the European Union and the World Health Organization (WHO).

Medochemie (Far East) Ltd. has 3 manufacturing plants in Vietnam:

Our latest strategic investments are the new manufacturing plants in Vietnam, operating in full compliance with current regulations for Good Manufacturing Practice (GMP) of the European Union and the World Health Organization (WHO).

  1. Oral facility (non-beta lactam) has started operating since May 2011, with a capacity of 2 billion tablets and 600 million capsules per year.
  2. Cephalosporin’s Injectable facility has started operating since June 2017, with a capacity of 55 million vials per year.
  3. Liquids & Semi-Solids facility has started operating since April 2018, with a capacity of 30 million bottles and 3 million tubes per year.

Additionally, one manufacturing plant is under construction in Vietnam and will start the production of Penicillin’s injectable (powder for injection/infusion) in a state-of-the-art facility by the end of 2022.

Medochemie Ltd. offers also capacity of 15 million suppositories per year in a EU GMP approved manufacturing plant located in Cyprus.

Medochemie is offering a wide range of dosage forms and technologies
 

Solids
Dosage Forms Manufactured through Packaging forms
Tablets uncoated Wet granulation Blisters in PVC, PVC-PVDC, Alu -Alu
Tablets film coated Fry mix
Slow release tablets Spray granulation
Slow release Film coated tablets Compression Securitainers
Chewable tablets Encapsulation in hard gelatin capsules
Two-layer tablets Film coating
Hard gelatin capsules,containing powder or granule Organic solvents are handled in granulation and in film coating Sachets
Granules
Powders
 
Semi solids & liquids (non sterile)
Dosage Forms Manufactured through Packaging forms
Creams Double jacketed vessels with wide range of batch sizes (500L, 5000L) Tubes: Plastic, aluminum (5-100gr) Jars (250ml)
Gels Mixing and Homogenization
Ointments
Lotions Sanitization capability Bottles: PE, PET, PVC, Glass, with caps (30-300ml
Syrups
CIP systems
Suspensions
Solutions
 
Cephalosporin Injectable
Dosage Forms Manufactured through Packaging forms
Cephalosporine powder for solution for injection or infusion Vial washing and sterilization/ Depyrogenation tunnel, filling and capping (BOSCH) Vials (250mg -2g)
 
Suppositories
Dosage Forms Manufactured through Packaging forms
Suppositories Minimum quantity to be produced 60kg
Maximum quantity to be produced 100kg
Equipment: SARONG SpA
Minimum filling dose: 0.5ml = 0.6g
Maximum filling dose: 3.7ml = 3.5g
Alu foil width 59mm. The machine can currently execute Alu foil cavities, but the pre-arrangement for PVC format has already been done.


The CMO services that we are offering are:
  • Manufacturing
  • Packaging
  • QC Testing
  • Analytical services
  • Supply Chain management
  • Regulatory support and advise

Advantages of having as partner Medochemie for contract manufacturing activities in Vietnam

  • Medochemie (Far East) Ltd is the only company in Vietnam that offers CMO activities in Vietnamese EU GMP approved manufacturing sites. Thus we offer a unique opportunity to companies that:
    • Want to expand in Vietnamese and neighboring markets such as Australia, Korea, Thailand, Malaysia and Philippines.
    • Have established sales in Asian and EU markets and want to increase their margin by contract manufacturing the finished products in Asia.
    • Want to partner with an established, reliable and trustful European company with significant experience and strong presence in Southeast Asia
  • All our sites are EU and TGA GMP approved and have dedicated teams, responsible for the tech transfer activities.
  • We can offer a full cost service with competitive prices.
  • We can provide regulatory services for Vietnamese market (preparation, submission and approval of Dossiers).
  • Ho Chi Minh City has a well-connected port and Medochemie Far East will be fully responsible for the export and shipment arrangement under CIF terms to Asia and Europe.
  • Regarding the Vietnamese market, our partners will have a competitive advantage since local regulations oblige 70% of the volume, to be given to locally produced products. Also, local tenders give priority and category 1 prices to products locally produced in EU GMP manufacturing sites.
  • Currently we are a partner of choice for CMO activities for originator companies like Pfizer and Janssen.

To Partner with us, contact