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ZACH - Zambon Chemicals is a leading European pharmaceutical chemical provider with two manufacturing sites at Lonigo/Italy (Veneto Region) and Avrillé/France (Western France). Headquarters is located in Northern Milan, Bresso, a total of 470 collaborators are dedicated to pharmaceutical chemistry.

Manufacturing sites are FDA inspected and compliant with national and international rules and regulations for quality standards

Both manufacturing sites are FDA inspected and compliant with national and international rules and regulations for quality standards, health, safety and environmental protection. ZACH makes part of the privately owned Zambon Group, founded in 1906. Group revenues achieved €562 Mio.

In 2011, ZACH realized revenues of €118 Mio with a split of one third each for Contract Manufacturing, generic APIs and production of APIs for captive use by Zambon Pharma. The lately formed business unit for pharmaceutical dossiers of ZACH shows steady growth.

The Lonigo site has 741 m3 reaction capacity organized in almost 100 reaction trains and manufactures large volume APIs with quantities of more than 500 tons/year per API.

The French site in Avrillé with 100 m3 reaction capacity takes a strategic role for the development and production of clinical phase cGMP APIs and produces a number of intermediates and APIs for pharma customers. The accommodation of products depends on customers preferences, regulatory aspects and capacity allocation.

ZACH’s Research & Development focuses on process scale-up and industrialization to provide our facilities with high quality and cost competitive processes.

Continuous innovation sets the process standards for the future in specific areas such as batch and continuous Ozonolysis, highly sophisticated crystal morphology and polymorph analysis using Synchrotrone beams with unprecedented resolution. ZACH owns more than 300 granted patents and adds continuously new filings to its portfolio.

In a highly competitive business environment, ZACH provides large capacity and sophisticated process chemistry for Active Pharmaceutical Ingredients and advanced intermediates. A longstanding company tradition is continuously generating innovative processes within the complex pharmaceutical supply chain to the patient.

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HQ- Commercial offices
Zach System S.p.A.
Via Lillo del Duca, 10
20091
Bresso (MI)
Italy
Production Site
R&D Site
Via Dovaro
36045
Almisano di Lonigo (VI)
Italy
Production Site
Zach System S.A
R&D Site
Z.I. la Croix Cadeau B.P. 10079
49242 Avrillé Cedex
France

Key Employees:

Roger Laforce
CEO

Girard Nicolas
M&S Generics

Kolaxidis Elena
Business Development Custom Synthesis

Livius Cortarca
Director R&D

Sara Lauria
Business Development Dossiers Generics

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Dossiers

Zach is dedicated to the worldwide development and registration of pharmaceutical generic drugs either using APIs from its internal pipeline or from selected API suppliers, exploiting its pharmaceutical expertise and, where possible, its corporate FP manufacturing sites. Focus is on high quality and strong control of the entire dossier development process from a regulatory standpoint.

Our portfolio includes several ophthalmics, niche and difficult to formulate products either injectables or solid oral dosage forms.Our services include (but are not limited to):MA licencingDossier licencing (for customers to be MAH)Technical information included in our dossierDossier development consultancy

Generic APIs

With a broad range of technologies available in our 2 plants both FDA inspected and located in Italy and France, Zach is developing new generic APIs for all markets. We are able to manufacture Kilo-lab quantities as well as hundreds of tons of APIs. Our strong experience in filing all over the world is allowing us to support our customers on global basis.

Our portfolio is made of a mixture of large volume APIs like Gabapentin or N-AcetylCysteine and complex molecules like Nebivolol for which we have various patents. Moreover, we have developed collaboration with an Indian company manufacturing some APIs in exclusivity for us based on process developed by Zach.
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