Manufacturing solutions for the health care industry
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Esteve química. Intermedios avanzados y principios activos farmacéuticos para la industria farmacéutica

Beyond API manufacturing. Understanding your specific needs and providing tailor-made solutions.

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Capabilities

Tailored-made solutions to meet your needs.

With broad experience integrating new technologies in our manufacturing sites, we provide viable solutions for our customer’s products.

We have extensive experience introducing new technologies -starting off with hydrogenation processes in the 80’s and, more recently, adding flow-chemistry processes.

In the Particle Engineering field, we have extensive know-how in particle size reduction technologies like milling and micronization. We supply these technologies on a small-to-commercial scale basis in all our manufacturing sites.

Additionally, spray-drying technology for the manufacturing of pharmaceutical intermediates has been recently introduced.

All these technologies are strongly supported by state-of-the-art analytical techniques such as laser diffraction, XRPD, DSC, and PAT.

Our lean management structure, with accessible leadership and very focused on the business, allows fast decision making processes to introduce new technologies, as well as designing models of cooperation to support the investment required.

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Facilities

Manufacturing is our core activity and our manufacturing sites are our main assets.

Strategically located in three continents —Europe, Asia and America— our 4 full cGMP state-of-the-art multipurpose manufacturing sites provide a total reaction volume capacity of 768m³ to guarantee perfect solutions for chemical and pharmaceutical intermediates or APIs.

Our pharmaceutical approach to chemical manufacturing (class 100,000 clean rooms for the last steps of synthesis) ensures full control of our products and processes according to the strictest quality standards.

A continuous investment policy keeps our manufacturing sites on a perfect compliance status by allowing us to implement new production technologies, such as Spray Drying, flow chemistry, HPAPI manufacture, etc...

Our global R&D team gathers 107 people and ensures that the knowledge on processes and new technologies is spread to all our manufacturing sites. Our global compliance management guarantees a European design, manufacturing and control in all our facilities.

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  • people dedicated to customer’s projects

  • manufacturing sites strategically located in 3 continents

  • total reaction volume capacity

  • (2015 estimated turnover)

Europe

CELRÀ, SPAIN

Located 108km north of Barcelona, Celrà manufacturing site employs 196 people and has a reaction volume of 329m³ with the following capabilities:

  • Scale-up multipurpose plant with technical and class 100,000 clean areas
  • Industrial multipurpose plant with technical and class 100,000 clean areas
  • Hydrogenation unit
  • Industrial low temperature reaction capabilities
  • Physical treatment unit with sieving, milling and micronizing capabilities
  • Industrial Spray Drying capability (operational in June 2016)
View Celrà inspection status
BANYERES DEL PENEDÈS, SPAIN

Located 72km south of Barcelona, Banyeres del Penedès manufacturing site employs 50 people and has a reaction volume of 52m³ with the following capabilities:

  • Scale-up multipurpose plant with technical and class 100,000 clean areas
  • Industrial multipurpose plant with technical and class 100,000 clean areas
  • Physical treatment in clean areas
  • Industrial HPAPI manufacturing capability (operational in June 2016)
  • Industrial low temperature reaction capabilities (operational in April 2016)
View Banyeres inspection status

Asia

SHAOXING, CHINA

Esteve Huayi Pharmaceuticals Co., Ltd (EHP) is a joint venture between Esteve Química Group in Spain and Huadong Medicine Group in China, where Esteve Química has a majority of 77%. EHP manufacturing site in Shaoxing is located 178km South-West of Shanghai City, employs 263 people, and has a reaction volume of 247m³ with the following capabilities:

  • Scale-up multipurpose plant with technical and class 100,000 clean areas
  • Industrial multipurpose plant with technical and class 100,000 clean areas
  • Hydrogenation unit
  • Physical treatment unit with sieving, milling and micronizing capabilities
  • Additional 100m³ reaction capacity, coming soon
View Shaoxing inspection status

America

JIUTEPEC, MEXICO

The fully-owned subsidiary of Esteve Química in Mexico, Sintenovo, S.A. de C.V Jiutepec manufacturing site, is located 95km south of Mexico City. The Jiutepec site employs 131 people and has a reaction volume of 139m³ with the following capabilities:

  • Scale-up multipurpose plant with technical and class 100,000 clean areas
  • Industrial multipurpose plant with technical and class 100,000 clean areas
  • Hydrogenation unit
  • Physical treatment in clean areas, including sieving, milling and micronizing
  • Additional 100m³ reaction capacity, coming soon
View Jiutepec inspection status

Reliability

Our strengths. Your guarantee.

We have established a well-designed Supply Chain Management (SCM) —from raw material storage through work-in-process inventory to final API— to ensure that short time-to-market and long-term support are provided to our customers.

Organizations know that they must rely on effective supply chains or networks. This concept of business relationships extends beyond traditional enterprise boundaries.

We work in compliance with cGMP guidelines —from process research, pilot scale and scale-up to commercial manufacturing— in close partnership with our customers to understand their specific needs and provide them with a tailor-made, responsive approach.

Our partners benefit from a specifically selected investment strategy in resources and experience in order to bring new technologies to market. With our vast experience in contract manufacturing and the generic fields, we help our partners translate ideas into commercial innovative success.

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Quality
Compliance

Being up to date and agile enough to support the customer as needed.

Esteve Química has always been an internationally oriented manufacturing company committed to the high quality standards of pharmaceutical industry.

Our reliability derives from high standards of quality, supply chain management, engineering and maintenance, as well as from accountability and flexible practice.

Our facilities are regularly inspected by Health Authorities (FDA, European Authorities, PMDA…). The continuous implementation and follow-up of cGMPs, added to our fully dedicated Customer Service and Regulatory Affairs teams, allows our global quality system to meet the highest standards of compliance with the flexibility required to adjust to our customers’ needs.

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Inspection status

Our facilities have been successfully inspected by relevant health authorities, with the first FDA inspection in September 1978.

Europe

Celrà manufacturing site, Spain
  • GENERALITAT DE CATALUNYA (National Authorities)

    September 2015

  • MFDS (Korean Authorities)

    April 2015

  • FDA (US Authorities)

    November 2013

  • PMDA (Japanese Authorities)

    April 2007 on-site

We also have had several PMDA GMP documentary inspections linked to the DMF and products we regularly market in Japan.

Banyeres manufacturing site, Spain
  • FDA (US Authorities)

    April - May 2013

  • AEMPS (National Authorities)

    September 2012

  • MFDS (Korean Authorities)

    December 2011

Barcelona R&D Stability site, Spain
  • GENERALITAT DE CATALUNYA (National Authorities)

    July 2015

  • FDA (US Authorities)

    February 2015

Asia

Shaoxing manufacturing site, China
  • FDA (US Authorities)

    March 2015

  • CFDA (National Authorities)

    June 2013

  • AEMPS (Spanish Authorities)

    May 2011

America

Jiutepec manufacturing site, Mexico
  • COFEPRIS (National Authorities)

    June - July 2013

  • PMDA (Japanese Authorities)

    May 2013

  • AEMPS (Spanish Authorities)

    September 2010