FCC. More than simply an API
At FCC, we supply excessive exceptional energetic pharmaceutical components that are used to enhance patients’ lives worldwide. While doing so, we guard our employees, the surroundings and our products. With quality, compliance and collaboration at the core of our DNA, we constantly attempt to enhance and furnish the remaining solutions for our customers.

Power of our People
Our proactive great and protection subculture is firmly rooted in our people: a team of workers of over four hundred personnel who are energetic, dedicated and enthusiastic. We apprehend your wishes and make contributions proactively by means of supplying greater environment friendly inexperienced alternatives. Our humans shape a effective groundwork for each and every new, sustainable improvement in our non-stop power to grant unparalleled and special solutions.

Power of Reliability
Our inexhaustible, deep-rooted basis for complex, effective APIs is constructed on 60 years of history. We are acknowledged as a dependable API provider. This is encouraged through our customers, as properly as worldwide regulatory authorities, together with the US FDA, EDQM, and PMDA. Weekly we welcome (virtual) inspection groups to our web sites and take pleasure in efficiently achieved inspections.

Power of Collaboration
We strongly consider in the chemistry of collaboration at all levels of API production. Whether your assignment is for a new chemical entity (NCE), or a method for (re-)designing your (intermediate) API, we will accomplice with you from the improvement section to the business implementation. Our crew of surprisingly knowledgeable specialists trip with you each step of the way thru non-public interaction, co-creation and tailored options to make certain that your task is a success.

Power of Innovation
Our improvement group commits itself to comprise innovation and inexperienced science into your projects. Being proactive and energetic, we include contemporary expertise and innovation. Our shut contacts to academic establishments additionally permits us to preserve up with the ultra-modern trends and to supply modern solutions.

Power to the Planet
Sustainability is extraordinarily necessary at FCC. In our effort to hold this world for generations to come, we attempt to reduce our carbon footprint. We exercise what we preach: we use inexperienced science and solvents in our chemical methods the place feasible and we attempt for greater environmentally pleasant alternatives.

Our Quality & Regulatory
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At FCC, we work from a deeply rooted and proactive nice culture. Our excessive pleasant merchandise are manufactured in compliance with cGMP, ICH and SHE guidelines and standards. Teamwork via quite motivated, skilled and expert specialists is one of our key success factors. We all make a contribution as fine is at the coronary heart of what we do.

Extremely excessive standards
Our compliance requirements are extraordinarily high. It is in our DNA to provide excessive great APIs used for completed dosage varieties that make a contribution to enhancing patients’ lives worldwide, in the meantime defending our employees, the surroundings and our products. Our Quality Control Laboratories comply with ICH hints – mainly cGMP’s & ALCOA standards – and are succesful of performing all trying out in help of the product range.

Stringent controls
Our Quality Control Laboratories structure an crucial phase of our cGMP manufacturing network. Stringent controls are utilized for chemical beginning materials, in-process controls and the massive characterization of closing products. We make sure fine APIs are manufactured in compliance with the applicable guidelines and regulatory file such as, for example, US FDA DMF, CEP and J-DMF.

Successful audits
Our amenities are correctly inspected and authorized via our clients and regulatory authorities such as the US FDA, EDQM and PMDA. Authorities and clients praise us for excellence in imposing records integrity in the organization.

Our regulatory excellence
We have complete regulatory journey in international locations all over the world. We know, are involved, and act proactively on modifications in monographs and on governmental guidelines and expectations. Customers depend on our excessive excellent dossiers and customer-oriented aid and we grant assurance that their API task is in skilled hands.

Our Sustainability
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At FCC, the safety of our employees, the surroundings and our products are quite valuated. We are dedicated to make sure a proactive security subculture and reflect onconsideration on Safety, Health and Environment (SHE) focus and compliance as an imperative. We manipulate SHE as an indispensable section of our enterprise and we are an ISO 14001 and ISO 45001 licensed company. Our committed group of in-house SHE experts ensures non-stop enchancment in SHE administration and performance.

Our important goals are to create a protected and wholesome working surroundings for our employees, contractors and partners, to reduce our influence on the surroundings and to cope with uncooked substances and power efficiently. We experience the want and the accountability to do so.

We are all responsible
We accept as true with that SHE administration is the vital duty of all of us in this organization: employees, contractors and companions who raise out work at our sites. We are continuously promotion a proactive SHE cultures in which we display possession of our SHE overall performance and make contributions closer to enhancing it. In an open ecosystem all of us is requested to call others to account. We additionally contain and seek advice from our personnel in the execution of the SHE policy.

Compliance to SHE requirements
We are dedicated to working in compliance with all felony SHE requirements, different necessities that the business enterprise subscribes to or that most important stakeholders insist upon. We work in accordance with SHE requirements ISO 14001 (environment), ISO 45001 (safety) and we hold licensed structures for this purpose.

Identifying and controlling SHE hazards
Adequate assets and services are made reachable to discover and manage SHE hazards. We purpose to stop illness, accidents and environmental incidents by means of keeping off or minimizing fitness and security risks. Risks are systematically identified, and measures are taken to control them. The desire of measures is primarily based on the occupational hygiene strategy.

Save the planet
In our effort to retain this world for generations to come, we strive to reduce our carbon footprint. We stop environmental air pollution (soil, water, air) and nuisance (odour, noise) and restriction environmental have an impact on (energy, water and uncooked fabric consumption, and waste production). We do this through using fantastic processes, working practices, substances and products. Application of Best Available Techniques is our beginning point. Specifically, we center of attention on decreasing greenhouse fuel emissions. We attempt to pick environmentally pleasant chemical substances and solvents in our processes.

Continuous improvement
It is our goal to consistently enhance our SHE overall performance by means of taking all moderately and sensible measures. Continuous enchancment can be established by using placing measurable SHE targets, the development of which is monitored and, if necessary, adjusted.

Transparent communication
We understand that obvious conversation is critical for profitable compliance. Our SHE dreams and consequences are typically communicated to our stakeholders. We attain out to our employees, government, enterprise companions and neighbours to are trying to find dialogue, in an open atmosphere. We exhibit them around, we pay attention to their suggestions. We go the greater mile to continuously enhance our SHE performance. Not solely due to the fact we have to, however due to the fact we favor to.

The SHE coverage is reviewed yearly to make certain that it is regular with the company’s imaginative and prescient and values and can be made accessible on request.

Through our world API network, we make sure flexibility and shipping reliability

Fine Chemicals Corporation,
Cape Town, South Africa
Fine Chemicals Corporation, a completely owned Aspen subsidiary, is placed in Cape Town, South Africa.

The manufacturing amenities at FCC are divided into ten manufacturing constructions and the whole manufacturing processing place underneath roof inclusive of mezzanines quantities to 6965 m2. The uncooked substances and completed items shops contain a in addition 3388 m2. The whole website online region in 2,7 ha / 27000 m2.

Inspection approvals
US FDA, PMDA, TGA, SAHPRA, EDQM/ANSM

Location Boxtel,
The Netherlands
Aspen runs a biochemical operation in Boxtel. In this devoted facility, urine from pregnant girls is amassed and similarly processed into the last API Chorionic Gonadotrophin (HCG).

In 2018 this facility has gone through a foremost renovation along with constructing a modern-day purification suite and the introduction of a virus filtration step, thereby assembly international regulatory requirements.

Inspection approvals
Dutch HA, PMDA, Russian HA, Turkish HA, US FDA.

Aspen Location Moleneind Oss, The Netherlands
Location Moleneind, Oss, The Netherlands
The Moleneind web page is placed in the coronary heart of Oss. Numerous things to do are carried out on site, together with peptide manufacturing, biochemical manufacturing and small-scale chemical manufacturing.

Also our Process and Analytical Development, our steadiness chambers, Quality Control and Quality Assurance departments are placed at Moleneind.

Inspection approvals
ANVISA, Dutch HA, KFDA, PMDA, Russian HA, Turkish HA, US FDA.

Location De Geer,
Oss, The Netherlands
The Diosite (‘De Geer’) facility is devoted to chemical manufacturing and includes a modern, computer-directed, multi-purpose manufacturing facility used for large manufacturing campaigns with response vessels up to a extent of 10,000 liters.

Also placed at this web page are the sieving, milling and micronisation of the APIs, as nicely as the central warehousing and distribution operations.

Inspection approvals
ANVISA, Dutch HA, KFDA, PMDA, Russian HA, Turkish HA, US FDA.

Location Sioux City, Iowa, USA
In our facility in Sioux City (Iowa, USA), we gather porcine mucosa and produce a crude heparin, that is then transported to our services in Oss for ultimate purification and product release. Having this Sioux City based totally facility in an necessary cattle vicinity in the USA, gives shut get entry to to many massive slaughterhouses, and for that reason to massive mucosa quantities. Large-scale mucosa series is crucial to be capable to constantly serve the world market desires for heparin sodium.

Our People
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At FCC, our group of workers of over four hundred personnel is proactive, enthusiastic, dependable and committed. We truly love molecules and our force is to collaborate and supply the last solution.

We strongly accept as true with in the chemistry of collaboration. Every step of your journey, from improvement to industrial implementation, we will be your partner.

Being quite certified and experienced, we recognize your desires and we make contributions proactively in discussing extra efficient, revolutionary and inexperienced selections for your assignment or product.

Quality, security and compliance are phase of our DNA. Our APIs are used in completed dosage varieties for sufferers worldwide. That makes us proud and responsible.

Tomorrow we’ll be higher than nowadays is no longer simply a quote. It is a way of being, living, working. We continually attempt to improve. Together we make initiatives and tactics smarter, greater efficient, and extra sustainable.

Contract improvement and manufacturing
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At FCC, your API undertaking is in terrific hands. With our abilities we can add price to your venture and collaborate with you to make certain success. We have a proud, 1/2 a century-long records in development, up-scaling and commercially manufacturing complicated excessive efficiency APIs (HPAPIs), as nicely as narcotics and other hooked up APIs.

Whether your undertaking is for a New Chemical Entity (NCE), or a manner for (re-)designing your (intermediate) API, we will be your companion from the improvement segment to the business implementation. FCC provides expertise, innovation, compliance, registration and partnership to your project. You will be working with a extremely good associate who provides capabilities and well-equipped pilot laboratories, pilot flowers and cGMP services to allow development, environment friendly technological know-how switch and scale up of your API.

Our amenities are effectively inspected and accredited with the aid of regulatory authorities such as the US FDA, EDQM, PMDA, and others. On pinnacle of that we truely love molecules, and we are pushed to information you to efficiently scale up from lab to plant.

Our trip with complicated chemical reactions permits us to improve the most environment friendly processes. Supported through a sturdy exceptional system, we make certain that a magnificent product is manufactured in compliance with cGMP, ICH and SHE regulations. FCC assures you of flexibility and shipping reliability to meet your assignment needs.

Our services
Direct contact with our Subject Matter Experts
Professional assignment administration
Route selection
Process improvement and optimization
Analytical improvement and validation
ICH balance studies
Extensive sourcing community for uncooked materials
Global regulatory information and support
Our API improvement skills includes
Dedicated R&D Tech crew with lengthy standing know-how in synthesis & manner development
Supported with the aid of Lab & Pilot Plants with Containment functionality of 50ng / m3 – 1 ug/m3
Well set up excessive knowledge CRO & CAS partners
Professional assignment administration
Extensive sourcing community for uncooked materials
Full analytical Development Services supported through ADD Lab
Manufacturing below full cGMP
Dedicated Regulatory knowledge and help
Patent investigations, improvement and filing.
HPLC, UPLC, LC-MS,
Access to college laboratories for high-resolution proton and carbon-13 spectrometry for ultra-modern correlation spectroscopy such as COSY and HETCOR
Access to college laboratories for SEM and X-ray powder diffraction studies
Thermal evaluation techniques, DSC, and TGA
Kilo scale manufacturing and drying gear

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