API Services

CONTRACT SERVICES OFFERED FOR API

  • API Contract Manufacturing. Manufacturing capabilities from our API plants in Spain and Malta.
  • HPAPI Contract Manufacturing. Manufacturing capabilities from our API plant in  Malta. We produce Class 4 HPAPIs with OEL down to 40 ng/m³ within cGMP and FDA inspected environments.
  • Flow Chemistry. Continuous flow reactor at industrial scale in our plant in Spain. Medichem can provide scale up services from R&D to industrial scale.

API PLANT IN SPAIN

02.01.02. CELRA (GIRONA - SPAIN) foto 203

In 1980, Medichem decided to relocate its manufacturing facilities in Celrà (Girona-Spain). From 1985, Celrà plant is frequently inspected by the USFDA (Food and Drug Administration). The last six consecutive FDA inspections were with no “Form 483” (the last one was in April 2015).

THE PLANT FOR REGULAR APIs IS DIVIDED INTO THE FOLLOWING SECTIONS:

PILOT PLANT

PILOT PLANT

Our Pilot Plant is an independent building used for process validation, process scale-up and also for some small scale pilot production for lots of 15 to 50 kg.

QTY EQUIPMENT DESCRIPTION
Reactors:

Total number: 7

Total capacity: 2m³

5 Glass-lined
1 Stainless-steel
1 Hastelloy
1

1

FILTERS:

Stainless-steel centrifuge

Hastelloy Nutsche-filter

1 Dryers:

Stainless-steel vacuum dryer

MANUFACTURING BUILDING I

MANUFACTURING BUILDING I

Manufacturing Building I is a multipurpose plant devoted mainly to the production of intermediates. It houses the necessary reaction and filtration equipment, for performing a wide range of reactions and for working in almost every process conditions enabling us to manufacture batches ranging from kilo to multi-ton quantities.

QTY EQUIPMENT DESCRIPTION REACTION CAPACITY
Reactors & tanks:

Total number: 19

Total capacity: 76m³

6

9

Reactors:

Glass-lined

Stainless-steel

21,5 m³

28,5 m³

2

2

Tanks:

Glass-lined

Stainless-steel

11 m³

15 m³

4

2

FILTERS:

Stainless-steel centrifuges

Stainless-steel Nutsche-filters

MANUFACTURING BUILDING II

MANUFACTURING BUILDING II

Manufacturing Building II is a multipurpose plant devoted mainly to the production of the last synthesis steps and finished APIs. It houses the necessary reaction and filtration equipment, for working in different process conditions and batch sizes, ranging from kilo to multi-ton quantities.

QTY EQUIPMENT DESCRIPTION REACTION CAPACITY
Reactors & tanks:

Total number: 11

Total capacity: 49,3m³

4

5

Reactors:

Glass-lined

Stainless-steel

16,3 m³

22 m³

1

1

Tanks:

Glass-lined

Stainless-steel

5 m³

6 m³

3

1

1

1

FILTERS:

Stainless-steel centrifuges

Halar-lined centrifuge

Stainless-steel filter dryer

Mill

HYDROGENATION UNIT

HYDROGENATION UNIT

Our Biazzi® Hydrogenation Unit is a GMP, multipurpose and independent plant. The design of the unit makes it suitable for working in a wide range of volumes and pressure.

QTY EQUIPMENT DESCRIPTION REACTION CAPACITY
1 Reactors:

Stainless steel

2m³
1 Catalyst feeding vessel:

Stainless-steel

160 L
1 Receiving Tank:

Stainless-steel

2 m³
1 FILTERS:

Stainless-steel catalyst filter

Utilities:

Blow down installation

Independent scrubber

Independent monofluid heating and cooling system

THE FINISHING AREA

THE FINISHING AREA

Our finishing areas are equipped with HVAC, air filtration, differential pressures, air-locks, etc.

In these plants we have the necessary equipment to dry the product and to obtain a wide range of particle size distribution: dryers, mills, shifters, micronizers, etc.

QTY EQUIPMENT DESCRIPTION
4 Dryers:

Stainless-steel vacuum dryer

1

1

2

Milling & Sieving equipment:

Pin mill

Conical mill

Centrifuge sifts

2 Micronizers:

Stainless-steel micronizers

API/HPAPI IN MALTA

Medichem Malta

THE PLANT FOR REGULAR APIs IS DIVIDED INTO THE FOLLOWING SECTIONS:

 

PILOT PLANT

PILOT PLANT

Our Pilot Plant is used for process validation, process scale-up and also for some small scale pilot production for lots ranging from 5 to 50 Kg.

QTY EQUIPMENT DESCRIPTION
Reactors :

Total number: 4

Total capacity: 1.5m³

2 Glass-lined
2 Stainless-steel
1 FILTERS:

Stainless-steel centrifuge

PRODUCTION PLANT

PRODUCTION PLANT

Our Production Plant is a multipurpose facility that is fully equipped for the synthesis of APIs. Reaction capacity 9 m3 easily expandable to 30 m3.

QTY EQUIPMENT DESCRIPTION REACTION CAPACITY
Reactors & tanks:

Total number: 3

Total capacity: 9m³

2 Glass-lined 6.5 m³
2 Stainless-steel 2.5 m³
1 FILTERS:

Stainless-steel centrifuge

THE FINISHING AREA

FINISHING AREA

The Finishing Area is where the last steps of the process are performed. It is equipped with HVAC, air filtration, differential pressure, air locks, etc. to prevent cross-contamination.

QTY EQUIPMENT DESCRIPTION
2 Dryers:

Stainless-steel vacuum dryer

1

1

Milling & Sieving equipment:

Pin mill

Centrifuge sift

1 Blender:

Stainless-steel drum Blender

THE HPAPI MODULAR LABORATORY

The HPAPI modular laboratory is dedicated to R&D and Kilo-Lab activities. The GMP kilo-lab unit includes:

QTY Equipment description
2 Reactors:
Total capacity: 30L
1 Filter
1 Dryer
1 Mill
1 Micronizer
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