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Inke to Triple Production Capacity

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Inke, a leading global manufacturer of inhalation APIs wholly owned by Neuraxpharm Group, announces it is investing €9 million to increase production capacity for inhalation APIs.

The investment will allow Inke to triple the production capacity of chemical synthesis and the micronisation of inhalation APIs at its manufacturing plant in Castellbisbal, Barcelona, by 2024. The company expects that approximately 80% of this €9 million investment will be deployed by the end of this year.

The expansion of Inke’s multipurpose plant allows the company to meet the increasing global demand for inhalation APIs: Urbanisation, especially in emerging markets, leads to a worsening of air pollution making respiratory diseases more prevalent. Furthermore, a global aging population is associated with increased susceptibility to respiratory diseases, which is expected to further drive the need for inhalation therapies.

With this investment, the company further builds its position as a leading specialist for the development and manufacturing of high-added-value APIs for the use in respiratory therapies. Its specialised capabilities, with over 20 years of in-house experience in micronisation and particle engineering to find the right crystal shape and particle size, make Inke an expert in the development of APIs.

Inke combines complex synthesis processes with best-in-class technical and manufacturing capabilities, and high regulatory expertise in key markets worldwide, such as the US or the EU. It has established preferential relationships with the main inhalation players worldwide and unique access to the highly demanding Japanese market.

With Inke’s expansion, the manufacturing plant will continue to adhere to the very stringent quality standards required for the manufacturing of respiratory products for inhalation.

Commenting on the investment, Dr. Jörg Thomas Dierks, CEO of Neuraxpharm, said: “Inke is a key supplier to major generic and branded companies in over 40 countries due to its very strong and entrenched competitive position. The segment of micronised inhalation APIs is highly attractive and poised for future growth, and I am convinced that this investment contributes significantly to extending our leading position in this market.”

Miquel Bachs, General Manager of Inke, added: “We expect the increased global demand for respiratory APIs will allow us to grow our business considerably and to further strengthen our market position as a leading global API supplier specialised in inhalation therapies. I am proud that with this investment, Inke’s production site in the province of Barcelona is made future-proof.”

Inke’s dedicated operational team includes manufacturing, R&D, regulatory, commercial, administrative, and other support functions to provide an end-to-end service through highly skilled experts. After introducing Miquel Bachs as General Manager in 2018, Inke has had a new management team driving the commercial strategy focused on third-party sales and a successful customer base and has expanded internationally. This strategy’s success becomes evident through Inke’s strong track-record of double-digit growth.

Inke developed its first respiratory product in 1998. Today, the site produces 34 APIs by chemical synthesis processes and is among the top three European respiratory API pharmaceutical manufacturing companies with most patent filings in the last ten years. The company has been successfully inspected by every major global authority, including the US-FDA since 2002 and the Korean FDA since 2012. It holds EU-GMP, ISO 9001, ISO 14001 certifications.

Inke is a leading global manufacturer of inhalation active pharmaceutical ingredients (APIs) established in 1980 and based in Castellbisbal (Barcelona, Spain). With more than 25 years of experience in respiratory APIs, the company focuses on the development and manufacturing of high‐added-value active substances for the pharmaceutical industry for use in inhalation therapies.

The company holds great expertise for the treatment of respiratory diseases like asthma and chronic obstructive pulmonary disease (COPD). This qualifies Inke to be a key supplier to major generic and branded companies worldwide, having twelve respiratory APIs for inhalation in its portfolio and distributing its products to more than 40 countries including Europe, the US, Japan, Korea, China and Turkey.

Inke has been successfully inspected by every major global authority, including the US-FDA since 2002 (latest inspection in April 2019). It is full EU-GMP compliant and holds ISO 9001 and ISO 14001 certifications. The company has a strong regulatory track-record with 10 Certificates of Suitability (CEPs), 10 US-DMF, 8 JP-DMF, 9 KR-DMF and 5 CN-DMF.

Inke is a wholly owned subsidiary of Neuraxpharm since 2016, a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders backed by funds advised by Permira.

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