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Sodium bicarbonate from the CIECH’s factory in Germany has received a pharmaceutical market authorisation

CIECH Soda Deutschland (CSD) has obtained the prestigious GMP (Good Manufacturing Practice) certificate, attesting to the highest quality of sodium bicarbonate production. This allows the German company of the CIECH Group to enter the promising pharmaceutical market. At the same time, CSD has procured and obtained a positive opinion of the local pharmaceutical office and was entered into the European EudraGMP database as a manufacturer of sodium bicarbonate in the medicinal product active substance standard. This confirms the highest quality production standards in the CIECH Group’s factory in Germany, as well as the exemplary physical and chemical properties of the sodium bicarbonate manufactured in this plant, allowing for its use in the production of medicines and medical devices. After the launch of the new production line in 2019, the production capacity of the Stassfurt plant is over 100 thousand tonnes of sodium bicarbonate per year. The CIECH Group is the second largest manufacturer of sodium bicarbonate in the European Union, sold under the SOBIC brand.

 

The obtained certificate and entry into the European manufacturer database open up the possibility for the German company to expand in the pharmaceutical sector. Sodium bicarbonate manufactured at CSD complies with the latest Pharmacopoeia (Pharmaceutical Code) in the area of its quality, composition and purity. This soda is characterised by the highest degree of purity and strictly defined granulation parameters. This product’s physical and chemical properties are regulated by strict quality restrictions and verified by regulatory authorities and customers. As an additional advantage of the production lines of CIECH Soda Deutschland, the product may be tailored to the individual customer order in terms of its physical properties.

 

The use of sodium bicarbonate as an active substance in the European Union and the USA allows its application, among others, in the production of dialysis fluids, in the treatment of cystic fibrosis (inhalation), metabolic acidosis, as well as a mild antiseptic or component of oral hygiene products. In recent years, sodium bicarbonate, in the form of an active substance, has been widely applied also in cosmetology and dermatology, as well as the food sector, where it can be used as an ingredient of dietary supplements and in the production of effervescent tablets and powders.

 

The sodium bicarbonate sold by the CIECH Group under the SOBIC Health Care brand, approved for use in the pharmaceutical industry, comes from a new production line launched in 2019 in the factory in Stassfurt, Germany. The value of the investment was approximately PLN 100 million. Currently, the German CIECH factory is able to produce up to 50 thousand tonnes of the highest quality sodium bicarbonate, with a total capacity of 110 thousand tonnes per year. Apart from the new production installations, new warehouses were also constructed that meet the high quality standards necessary for the storage of soda used in the production of medicines.

 

- The extension of the CIECH Group's offer to include highest quality pharmaceutical-grade sodium bicarbonate from Germany is not only an opportunity to enter new, prospective markets, but also a confirmation of the use of good manufacturing practices, stability of the production process, technological excellence, as well as vast expertise and professionalism of our employees. 2021 will be the first year in which we will fully use the potential of the new production line in Germany, both in terms of production capacity and offering customers the highest quality product, confirmed by certification and numerous audits. This is a significant step in the implementation of the Group's strategy, aimed, among other things, at consistently increasing the share of specialised products in the CIECH’s portfolio – says Dawid Jakubowicz, President of the Management Board of CIECH S.A.

 

CIECH produces sodium bicarbonate under the SOBIC brand in its plants in Germany and Inowrocław. The Group’s total production capacity in this area is approx. 200 thousand tonnes per year, which makes CIECH the second largest manufacturer in the European Union. Sodium bicarbonate produced by the Group has a very wide range of applications and is used in the food industry (SOBIC Food), pharmaceutical and cosmetics industries (SOBIC Health Care), as well as feed (SOBIC Feed), chemical (SOBIC Tec) and energy industries (flue gas purification) – under the Sorbeco brand. This product has broad applications due to its acid-neutralising properties, ability to bind other substances and abrasive qualities that help remove dirt from different surfaces.

 

CONTACT DETAILS

Mirosław Kuk, Press Spokesperson of the CIECH Group

miroslaw.kuk@ciechgroup.com, tel. +48 723 66 86 86

 

CIECH is an international, expanding chemical group, with a strong standing on European and global markets and with a stable strategic investor (Kulczyk Investments). The company exports its products to over 100 countries around the world, including soda ash, purified soda, salt, plant protection agents, epoxy and polyester resins, polyurethane foams, silicates, and glass packaging. CIECH manufactures products of the highest, world-class quality, which are further used to produce articles which are essential in the everyday life of people all over the world. At the same time, it combines a modern approach to business with the tradition of production which dates back to 1882. Since 2005, the company has been listed on the Warsaw Stock Exchange and, since 2016, on one of the largest stock exchanges in Europe: Börse Frankfurt.

More information is available at www.ciechgroup.com.

 

CIECH Soda Deutschland - a German manufacturer of soda ash based in Stassfurt. The company produces soda ash and sodium bicarbonate (including its most specialized type, intended for pharmaceuticals). It is one of the oldest companies in Saxony-Anhalt. The history of the company dates back to 1882, in the CIECH Group since 2007. Currently, the construction of a new CIECH salt works plant is underway in the vicinity of the factory - it is the largest greenfield investment in the history of the Group, worth approx. EUR 140 million.

 

1 The GMP certificate confirms that, according to EU law, the manufacturer operates in accordance with good practices in terms of production, transport and storage of raw materials for the pharmaceutical industry.

2 The European EudraGMP database is a list of manufacturers, i.e. approved producers of active substances for pharmaceutical use, coordinated by the European Medicines Agency.

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