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Industrial Operations

Pharmaceutical Manufacturing Plants

Recordati’s production sites are equipped with state-of-the-art installations and their research laboratories are fitted with the latest equipment.

 

All plants operate in full compliance with environmental protection regulations and in compliance with the cGMP (current Good Manufacturing Practices).

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Pharmaceutical Chemical Plants

The manufacturing of active ingredients has been a core part of Recordati’s history since it was founded in 1926 with Giovanni Recordati transformed the Pharmacy and adjoined chemical laboratory into the “Laboratorio Farmacologico Reggiano”, resulting in the birth of Recordati as a chemical pharmaceutical industrial company.  Since moving its main operations to Milan, the division has grown internationally alongside the broader pharmaceutical business, exporting 90% of its production of APIs and intermediates, selling directly in over 50 Countries and manufacturing intermediates and active ingredients for the Recordati pharmaceutical brands.

A huge variety of vertically integrated operations allow to obtain top quality products starting from very simple raw materials, by managing extremely complex chemical processes. The capabilities related to the utilisation of substances requiring special risk management measures and the possibility to carry out reactions in extreme conditions, such as high temperatures and pressures, are one of the most important components of the manufacturing expertise. A permanent effort is made to keep production lines and areas at the forefront of technology, with relevant investments aimed to continuously improve QHSE management and to develop production capacity, efficiency and flexibility.

Recordati’s Pharmaceutical Chemical Division is committed to establish and maintain a Quality System which meets the international guidelines, including but not limited to ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”, Eudralex Volume 4 Good Manufacturing Practice (GMP) Guidelines: Part II – “Basic Requirements for Active Substances used asStarting Materials”, Part III “GMP – related document” and Annex 11 “Computerized systems” and CFR 21 part 11. Recordati is recognised as a leader in the market of several high purity APIs and a reliable provider for compendial reference standards. Recordati’s cooperation with the pharmacopoeia expert committees started more than 20 years ago for the proposal of the compendial monographs for the APIs developed by Recordati and more recently Recordati cooperated in the revision of several compendial monographs to introduce high selective methods for related substances determination.

The R&D Department’s main duty is supporting the Recordati Business Development through the fine-tuning of new products and the manufacturing of APIs both for Recordati and other pharmaceutical companies. To this end, a complete set of manufacturing facilities is available both at lab and pilot plant scale, combined with the use of suitable softwares for the process development and tech transfer from the lab to the production plant.

The R&D Department is composed by a team of highly specialised researchers and technicians (5 PhDs in Chemistry, 5 Master’s Degree in Chemistry, 1 Process Engineer, 4 high school graduates) who master most of organic chemistry reactions and production technologies as well as short path distillation, high pressure hydrogenation, flow chemistry. Thanks to highly efficient discovery programmes issue as above, as well as wise alliances with other pharmaceutical and research institutes, Recordati has always been able to successfully implement new products in its portfolio. Commitment, scientific rigour and availability of technological capability in the R&D Department, allow Recordati to develop new treatments and to count on an always innovative product pipeline. In order to constantly ensure high API quality and robustness of the production, the R&D group is involved in a never ending performance improvement cycle; however, the main research and development activities are mainly focused on generating innovative treatments with special care on rare diseases.

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