Pharma Services Category of Fermion Oy

With Fermion, start the journey of your innovative API.

Pharma Service : Drug Product Manufacturing

Fermion, through its mother company Orion, offers contract manufacturing services for hormonal and non-hormonal semi-solids, including gels, creams, ointments and solutions with potent OEB 4-5 APIs.

Category : Gel

Sub Category : Overview

Pharma Service : Drug Product Manufacturing

02

API MICRONIZATION SERVICES

Finland

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Pharma Service : API Manufacturing

Fermion has a manufacturing module for separate final handling with a micronization area which is equipped with small-scale mills designed for APIs used in dry powder inhaler drug delivery systems. It is capable of handling OEB5 classified APIs.

Category : Micronization

Sub Category : Overview

Pharma Service : API Manufacturing

03

CYTOTOXIC API CONTRACT MANUFACTURING

Finland

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Pharma Service : API Manufacturing

Fermion is a contract development and manufacturing organization (CDMO) with two USFDA and EMA approved API manufacturing sites for the commercial manufacturing of cytotoxic APIs, steroids and conventional molecules.

Category : Cytotoxic Compound

Sub Category : Overview

Pharma Service : API Manufacturing

04

CONTROLLED SUBSTANCE API MANUFACTURING

Finland

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Pharma Service : API Manufacturing

Fermion is an API CDMO with dedicated resources for manufacturing class IV narcotics and large-scale immunosuppressants with a reactor capacity of 25 m3 for OEB5 (0.1 – 1 µg/m3) classified APIs at its Hanko site.

Category : Controlled Substance

Sub Category : Overview

Pharma Service : API Manufacturing

05

API CONTRACT MANUFACTURING SERVICES

Finland

With Fermion, start the journey of your innovative API.

Pharma Service : API Manufacturing

Fermion offers contract manufacturing services for drug substances with an API product portfolio consisting of over 30 generic APIs and over 10 NCEs. It also has the capability to produce highly potent compounds (HPAPIs).

Category : Contract Manufacturing

Sub Category : Overview

Pharma Service : API Manufacturing

06

CLINICAL SUPPLY OF APIs

Finland

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Pharma Service : API Manufacturing

Fermion’s API contract services cover the needs of customers from the clinical phase I stage until commercial production with extensive experience in NCE (new chemical entity) drug substance development and manufacturing.

Category : Clinical Supply

Sub Category : Overview

Pharma Service : API Manufacturing

07

ANALYTICAL METHOD DEVELOPMENT

Finland

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Pharma Service : Analytical

Fermion offers the development of analytical methods for starting materials (SMs), intermediate materials (IMs) and active pharmaceutical ingredients (APIs) for Phase I, II and III together with the validation of API analytical methods.

Category : Analytical Method Development

Sub Category : Method Development and Validation

Pharma Service : Analytical

08

DEVELOPMENT OF HIGHLY POTENT APIs

Finland

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Pharma Service : API & Drug Product Development

Fermion's R&D laboratory contains 55 fume hoods and has special laboratory spaces for hydrogenation & highly potent APIs (HPAPI). Fermion’s Oulu site focuses on smaller volume highly potent OEB5 APIs from a scale of 1-2kg per batch to one metric ton.

Category : API Development

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : API & Drug Product Development

09

DRUG SUBSTANCE DEVELOPMENT SERVICES

Finland

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Pharma Service : API & Drug Product Development

Fermion's contract development and manufacturing services cover the needs of customers from the clinical phase I stage until commercialization. It has extensive experience in NCE drug substance development and production since the 1990s.

Category : API Development

Sub Category : Overview

Pharma Service : API & Drug Product Development

10

API SCALE-UP CAPABILITIES

Finland

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Pharma Service : API & Drug Product Development

Fermion’s bench scale unit (kilo scale laboratory) is fully automated and equipped with high containment processing technology. It has the capability to commercially manufacture highly potent OEB5 APIs from a scale of 1-2 kg per batch to one metric ton.

Category : API Development

Sub Category : Scale-Up Capabilities

Pharma Service : API & Drug Product Development

11

CDMO FOR INTERMEDIATES & APIs

Finland

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Pharma Service : API Manufacturing

Fermion is a contract development and manufacturing organization (CDMO) comprising three manufacturing units for intermediates and APIs along with distillery, hydrogenation, maintenance, warehouses, QC laboratory, and administrative functions.

Category : Fine Chemical / Intermediate

Sub Category : Overview

Pharma Service : API Manufacturing

12

GMP MANUFACTURING FOR APIs

Finland

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Pharma Service : API Manufacturing

Fermion is a CDMO which has a bench scale unit fully automated and equipped with high containment processing technology. The unit manufactures APIs as per cGMP guidelines and has technical capabilities that include 10-30 L reactors.

Category : GMP Manufacturing

Sub Category : Overview

Pharma Service : API Manufacturing

13

HPAPI CONTRACT MANUFACTURING SERVICES

Finland

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Pharma Service : API Manufacturing

Fermion is a CDMO with manufacturing expertise in highly potent APIs, high-quality cytotoxics with three fully automated HPAPI modules for OEB5 (0,1 - 1 µg/m3) classified APIs with reactors of 250 L, 400 L and 600 L.

Category : High Potency APIs (HPAPIs)

Sub Category : Overview

Pharma Service : API Manufacturing

14

API PROCESS DEVELOPMENT

Finland

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Pharma Service : API Manufacturing

Fermion’s API contract development and manufacturing services include process development and custom synthesis with route suitability and impurity control (organic, mutagenic) for active pharmaceutical ingredients (APIs).

Category : Process Development & Optimization

Sub Category : Overview

Pharma Service : API Manufacturing

15

STEROID API MANUFACTURING

Finland

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Pharma Service : API Manufacturing

Fermion is a contract development and manufacturing organization (CDMO) with two USFDA and EMA approved API manufacturing sites for the commercial manufacturing of steroids, cytotoxic APIs and conventional molecules.

Category : Steroid / Hormone

Sub Category : Overview

Pharma Service : API Manufacturing

Capabilities
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16

CYTOTOXIC CAPSULE MANUFACTURING SERVICES

Finland

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Pharma Service : Drug Product Manufacturing

Fermion, through its mother company Orion, offers contract manufacturing services for capsules and tablets with expertise in highly potent, high-quality cytotoxics manufacturing.

Category : Capsule

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : Drug Product Manufacturing

Cytotoxic Capsule Manufacturing Services

17

HORMONAL & NON-HORMONAL CREAMS

Finland

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Pharma Service : Drug Product Manufacturing

Fermion, through its mother company Orion, offers contract manufacturing services for hormonal and non-hormonal semi-solid dosage forms, including creams, ointments, and gels, along with liquids such as solutions and suspensions with potent OEB 4-5 APIs.

Category : Cream / Lotion / Ointment

Sub Category : Overview

Pharma Service : Drug Product Manufacturing

18

POTENT & CYTOTOXIC TABLET MANUFACTURING

Finland

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Pharma Service : Drug Product Manufacturing

Established in 1982, Orion has acquired long-term expertise in manufacturing highly potent and high-quality cytotoxics. The focus areas of its drug product contract manufacturing services include cytotoxic oral solids, such as tablets and capsules.

Category : Tablet

Sub Category : High Potency APIs (HPAPIs)

Pharma Service : Drug Product Manufacturing

19

BLISTER PACKAGING SERVICES

Finland

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Pharma Service : Packaging

Fermion, through its mother company Orion, has a packaging and logistics center with three blister lines and four bottle lines and over 42 million blister packs and bottles.

Category : Contract Services

Sub Category : Blister

Pharma Service : Packaging

20

BOTTLE PACKAGING SERVICES

Finland

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Pharma Service : Packaging

Fermion, through its mother company Orion, handles the packaging and dispatching of over 42 million bottles and blister packs annually from its four bottle filling lines and three blister lines integrated with secondary packaging lines.

Category : Contract Services

Sub Category : Bottle

Pharma Service : Packaging

21

JAR PACKAGING

Finland

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Pharma Service : Packaging

Fermion, through its mother company Orion, has expertise in manufacturing tablets which are pressed with WIP-tablet press and packed into jars in a containment chamber. The products can be packed in plastic jars and serialized when needed.

Category : Contract Services

Sub Category : Jar

Pharma Service : Packaging

22

CONTRACT PACKAGING SERVICES

Finland

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Pharma Service : Packaging

Fermion, through its mother company Orion, offers stand-alone contract packaging with one major packaging and logistics center at Orion’s site in Salo. However, some departments may also have packaging operations integrated to the bulk production line.

Category : Contract Services

Sub Category : Overview

Pharma Service : Packaging

23

SACHET FILLING & PACKAGING SERVICES

Finland

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Pharma Service : Packaging

Fermion, through its mother company Orion, has one single-dose sachet filling and packaging line. Two bottle filling lines are integrated with secondary packaging lines with serialization and aggregation capabilities.

Category : Contract Services

Sub Category : Pouch / Sachet / Stick Pack

Pharma Service : Packaging

24

SECONDARY PACKAGING SERVICES

Finland

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Pharma Service : Packaging

Fermion, through its mother company Orion, provides bottle filling services integrated with secondary packaging, including serialization and aggregation.

Category : Contract Services

Sub Category : Secondary Packaging

Pharma Service : Packaging

25

SERIALIZATION & AGGREGATION CAPABILITIES

Finland

With Fermion, start the journey of your innovative API.

Pharma Service : Packaging

Fermion, through its mother company Orion, provides single-dose sachet filling, bottle filling and packaging services. Two bottle filling lines are integrated with secondary packaging lines, along with serialization and aggregation capabilities.

Category : Contract Services

Sub Category : Serialization Compliance

Pharma Service : Packaging

Serialization & Aggregation Capabilities