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Idifarma approved for EU-GMP commercial capsule manufacturing

3rd July, 2017

A Spanish contract development and manufacturing organisation (CDMO) has expanded its GMP manufacturing offering with the installation of new automatic capsule filling capabilities at its EU-GMP approved plant in Pamplona, Spain.

The new Bosch GKF-702 automatic capsule filling machine, which is capable of manufacturing up to 42,000 hard capsules per hour, is now fully operational and will support Idifarma in the manufacturing of small-scale clinical and commercial batches, as well as providing the ability to simulate industrial production environments during R&D.

Successfully audited by the Spanish Medicines Agency (AEMPS) in June, the GKF-702 strengthens Idifarma’s position as a specialised contract partner for the development and manufacturing of oral solid dosage forms, with a particular focus on high potent compounds and niche pharmaceutical products requiring small batches.

The new investment includes a minibowl for small R&D batches, resulting in a more efficient use of active pharmaceutical ingredients (APIs) and less wastage. The machine also comes equipped with an industrial PC (IPC) which is 21 CFR part 11 compliant and benefits from a variety of interfaces which makes the batch documentation easier to access.

Luis Oquiñena, general manager and co-founder of Idifarma commented: “The latest addition to our facility in Pamplona is a fantastic development for Idifarma, helping us to bolster our manufacturing capabilities and reinforce our position as a specialist CDMO for small-scale niche products in solid oral forms.

“The GKF-702’s modular design will help us to future proof our investment ensuring that we can add real value to our clients’ manufacturing and development projects over the coming years. It is important for us to remain versatile and flexible, however we will continue to focus on specialised low-volume and high potent pharmaceutical products which is a key differentiator for us.”

In addition to its expanded capsule filling capabilities, Idifarma has also recently invested in new analytical equipment at its Pamplona facility, including an Agilent gas chromatography system and dissolution apparatus, as well as four new Waters HPLCs to support its growing client base.

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Last Updated on Monday, 03 July 2017 10:23
 
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Investment in automatic capsule filling capabilities

November 2016

Idifarma has expanded its GMP manufacturing offering with an investment in automatic capsule filling equipment.

We have acquired a Bosch GKF-702 capsule filling machine, capable of manufacturing from 3,000 to 42,000 capsules per hour. The new equipment will be installed at our CDMO’s EU-GMP approved plant in Pamplona, Spain, in early 2017.

Commenting on the investment, Luis Oquiñena, general manager and co-founder of Idifarma says: “This is a significant milestone in our journey so far, helping us to become a leading CDMO for small-scale niche products in solid oral forms.

“Idifarma will continue to keep its contract manufacturing focus on specialised, low-volume pharmaceutical products where we can add real value to our clients’ projects involving innovative drugs and niche generics.

“This investment will also include the enlargement of our GMP plant with new rooms and capacity to handle high potency drugs, another clear differentiation and focus area for Idifarma.”

In addition to improving Idifarma’s contract manufacturing capabilities, the GKF-702 will also feature a “lab kit”, enabling the use of the machine during pharmaceutical development, resulting in a more efficient use of active pharmaceutical ingredients (APIs) and less wastage.

The new machine will benefit from other equipment that is already installed at Idifarma’s GMP plant including a Hüttlin Oyster high-shear mixer and dryer for wet granulation processes, bin blenders with capacity up to 70 kg and a Clinipack IMA blistering machine, with the ability to work with Alu/Alu or any thermo-formable material. Idifarma can also handle narcotics and low-humidity requirements.

Luis Oquiñena continued: “We are confident that this new investment will not only attract clients interested in production, but also contract development projects in hard capsule form in the coming months.

“Our customers can now benefit from a one-stop-shop service from lab-scale development to manufacturing of clinical batches and dossier compilation to specialised commercial manufacturing,” added Luis.

The investment in capsule filling equipment coincides with the 15th anniversary of Idifarma, which will grow its revenue in 2016 by over 25%. The team recently reached 100 people, with 50% of business now coming from outside of Spain.

Last Updated on Thursday, 09 February 2017 11:29
 
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IDIFARMA ON THE MEDIA


Contract manufacturing: roundtable

Idifarma participated in a CMO roundtable to share its insights into successful contract manufacturing strategies in April and May issues of Manufacturing Chemist magazine.

Part One: April, 2017 - http://bit.ly/2pqSLp4

Part Two: May, 2017 - http://bit.ly/2rIxUPu


Manufacturing Process Transfers in the Pharmaceutical Industry: A Best Practice Approach

14th March, 2017

Iñaki Bueno writes in the magazine Pharmaceutical Processing an interesting explanation about one of the most important steps in a pharmaceutical development: the process transfer.

http://www.pharmpro.com/article/2017/03/manufacturing-process-transfers-pharmaceutical-industry-best-practice-approach

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Oral Solid Dosage Outsourcing: Trends & Challenges

7th March, 2017

Manuel Leal, our Business Development Director, highlights in the Magazine “Contract Pharma” the opportunities and challenges offered by the niche products market and Idifarma’s strategic position to adapt to it.

http://www.contractpharma.com/issues/2017-03-01/view_features/oral-solid-dosage-outsourcing-trends-challenges/


Key Considerations in Capsule Filling

2nd March, 2017

Our Pharmaceutical Development Manager Iñaki Bueno shares his expertise on Key Considerations in Capsule Filling, magazine Pharmaceutical Technology

http://www.pharmtech.com/key-considerations-capsule-filling-0

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Perspectives for 2017

Our Business Development Director, Manuel Leal, gave his opinion about 2017 perspectives to the magazine European Pharmaceutical Manufacturer

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Both small and large CMOs to benefit from pharma capacity and agility demands

21-Nov-2016

Small CMOs could be very flexible and provide comprehensive solutions in the challenges of manufacturing small volumes, as we discussed in magazine In Pharma Technologies

http://www.in-pharmatechnologist.com/Processing/Both-small-and-large-CMOs-to-benefit-from-capacity-and-agility-demands

Last Updated on Monday, 05 June 2017 07:50
 
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Record growth for IDIFARMA

November 2016

Idifarma has grown by more than 50 per cent in the last two years as it continues to expand its international customer base and strengthen its specialist production capabilities.

Our revenue is estimated to reach around €5.3 million in 2016, growing from €3.5 million in 2014. To meet increased demand for its clinical and commercial capabilities, the team is expected to reach 100 employees in 2016, growing by a third from 75 in 2014.

Luis Oquiñena, general manager and co-founder of Idifarma, said: “Idifarma’s foundations have been built on strong development expertise and contract development projects continue to form around 50 per cent of our business. In recent years, we are supporting more and more clients with the development of highly potent drugs and other challenging products such as niche generics and innovative drugs.

“Our contract manufacturing services represent the biggest growth area of the business. Idifarma’s focus on low-volume, niche pharmaceutical products is meeting a largely unmet need in the industry at a global level.

“As a result, we are planning to make further investments into our manufacturing capabilities in the coming months and into 2017,” added Luis.

Over 50 per cent of the business now comes from outside of Spain, with strong markets including Germany, the Netherlands, Belgium, Sweden, Poland and increasingly outside of Europe.

Our company is currently investing in additional analytical equipment including ultra performance liquid chromatography (UPLC) and high performance liquid chromatography (HPLC) technology, increasing its chromatography capacity by over 50 per cent in the last two years.

Idifarma, which marks its 15th anniversary this year, specialises in assisting drug developers with complex formulation and development projects, with particular expertise in overcoming low solubility challenges thanks to its investment in spray drying technologies. The CDMO also has strong solid dosage form manufacturing capabilities for low-volume products, with a focus on tablet and capsule production and expertise in handling high potency products.

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Last Updated on Tuesday, 08 November 2016 11:10
 
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IDIFARMA at CPhI 2016

October 2016

From 4th to 6th of October, last CPhI Worldwide show took place in Barcelona.

It was a unique event to have meetings with several companies coming from all over the world, mainly European, and introduce our services in the fields of development and manufacturing (CDO and CMO). This year, an important number of people from our team attended the show, including our staff from technical areas, project management, general management and business development.

Moreover, in that event we celebrated our 15th anniversary with the members of our team as well as an important number of companies that has been working with us during these 15 years.

Next year, Idifarma will be present again in CPhI Worldwide in Frankfurt, from 24 to 26th of October 2017.


Last Updated on Wednesday, 16 November 2016 10:38
 
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XV Anniversary

November 2016

Last 11th and 12th of November the celebrations of the XV anniversary of Idifarma took place.

Friday 11th of November, in the facilities of Navarra Factori, in CEIN, an institutional event took place with the presence of employees and former members of Idifarma’s team, as well as representatives from the companies of the board of directors. Luis Oquiñena, general manager of the company, summarized the history of the company from its founding and initial stay in the facilities of CEIN, in 2001, till today, when the company hosts almost a hundred of employees and has around a 50 percent of international business.

In this event, a gift was given as recognition for the employees that have been present for 15 years in the company.

Following these celebrations, Saturday 12th of November an open day was celebrated, when the families and friends of the members of Idifarma could visit the facilities of the company. After a brief summary about history and capacities, the attendants visited the facilities and discovered the activities of the company performed in the different areas, in the offices as well as in the laboratories of analytical development, formulation development and in the GMP manufacturing plant.


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Last Updated on Thursday, 17 November 2016 10:38
 
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