Amoxicillin Manufacturing Hub: Exploring Austria's Pharmaceutical Sector

where in austria is amoxicillin manufactured

Sandoz, a global leader in generic and biosimilar medicines, opened an antibiotic manufacturing facility in Kundl, Austria, in November 2023, with an investment of €150 million ($160.4 million). The facility includes automation and state-of-the-art technology for API manufacturing and finished dosage forms (FDFs). The facility supports increased production capacity for FDF penicillin, the most widely used class of antibiotics worldwide. Sandoz also announced plans to invest over €100 million in new manufacturing technology for the production of oral amoxicillin API at the Kundl site.

Characteristics Values
Company Name Sandoz
Location Kundl, Austria
Investment Amount €150 million ($160.4 million)
Opening Date November 2023
Building Floors 3
Building Area 1875m²
Focus Bulk formulation and fill-finish activities for penicillins
Production Capacity Increased for finished dosage form (FDF) penicillin

shunculture

Sandoz's antibiotic manufacturing facility in Kundl, Austria

Sandoz, a global leader in generic and biosimilar medicines, has a manufacturing facility in Kundl, Austria, that produces antibiotics. The company has been producing quality antibiotics out of Kundl for the past 75 years.

In November 2023, Sandoz opened a new state-of-the-art antibiotic manufacturing facility at the Kundl site with an investment of €150 million ($160.4 million). The project was developed with an estimated investment of €150 million, including a €100 million investment from Sandoz and €50 million from the Austrian federal government. The facility includes automation and the latest manufacturing technology for API manufacturing and finished dosage forms (FDFs).

The new facility is part of a €200 million investment into the site in Kundl, to significantly upgrade penicillin API manufacturing and increase output of finished products. The expansion in finished dosage forms (FDFs) means that Kundl now has a production capacity of 240 million packages per year, more than double its 2021 output levels.

The new three-storey building is connected to the existing penicillin production facility in Kundl, expanding its footprint by 1,875 m² (20,182 ft²). The facility focuses on bulk formulation and fill-finish activities for penicillin, intended for global distribution. The expansion will support a double-digit increase in future output capacity for penicillins.

Sandoz CEO Richard Saynor said: "Antibiotics remain the backbone of modern medicine and we are seeing rapidly increasing demand following the unprecedented market swings of the past few years. This investment will help to meet that growing patient need, to support the creation of hundreds of new jobs, and to partially offset the impact of high energy prices by lowering unit costs."

The Many Tongues of Elizabeth of Austria

You may want to see also

shunculture

Amoxicillin production technology

Amoxicillin is a semisynthetic derivative of penicillin with a structure similar to ampicillin but with better absorption when taken orally. It is an antibiotic medication belonging to the aminopenicillin class of the penicillin family. It is used to treat bacterial infections such as middle ear infection, strep throat, pneumonia, skin infections, odontogenic infections, and urinary tract infections. It is typically taken orally, or less commonly by intramuscular injection or IV bolus injection.

The production of amoxicillin involves a process of acylation of silylated 6-aminopenicillanic acid with the appropriate acid chloride hydrochloride. This process increases the efficiency of the manufacturing process and the purity of the product. The end product is an antibacterial agent, commonly known as a semi-synthetic penicillin.

A patent outlines a specific process for the production of amoxicillin trihydrate, which involves the following consecutive steps:

  • Silylate 6-aminopenicillanic acid with chlorotrimethylsilane or hexamethyldisilazane in methylene chloride in the presence of triethylamine.
  • Acylate the silylated 6-aminopenicillanic acid with D-(-)-2-para-hydroxyphenylglycine chloride hydrochloride in the presence of dimethylaniline and its hydrochloride.
  • Hydrolyze and neutralize the product of the acylation to produce amoxicillin trihydrate.

This process produces amoxicillin trihydrate of better quality than other methods, with less colour, lower content of DMA, and improved potency due to reduced processing time. It also has the advantage of higher productivity and, in some cases, higher purity.

In terms of manufacturing facilities, Sandoz, a global leader in generic and biosimilar medicines, has invested in a key manufacturing facility in Kundl, Austria, to support the increased global demand for essential antibiotics, including amoxicillin. This investment includes new manufacturing technology for the production of oral amoxicillin active pharmaceutical ingredient (API). The facility in Austria will also include a new three-floor building connected to the existing penicillin production facility, focusing on bulk formulation and fill-finish activities for global distribution.

shunculture

Global demand for antibiotics

The global demand for antibiotics is expected to increase in the coming years, with the market projected to reach USD 54.78 billion by 2028 and USD 70.27 billion by 2030. This growth is driven by several factors, including the increasing prevalence of communicable diseases such as TB and HIV, the rising geriatric population, and increasing investments in research and development. Additionally, government initiatives to raise awareness about infectious diseases and antibiotics also contribute to the growing demand.

To meet this increasing demand, companies like Sandoz, a global leader in generic and biosimilar medicines, have invested significantly in expanding their manufacturing capabilities. In November 2022, Sandoz announced a EUR 50 million investment to increase manufacturing capacity for finished dosage form (FDF) penicillins, the leading class of antibiotics worldwide. This investment is part of their broader plan to drive long-term competitiveness and ensure the security of supply for critical penicillin medicines. The expansion includes a new three-floor building at their Kundl, Austria site, which will focus on bulk formulation and finish-fill activities for penicillins, allowing them to integrate all production steps into a single process and increase supply reliability.

The global antibiotics market is segmented by indication, including skin infections, respiratory, gastrointestinal, UTIs, bloodstream, clostridium difficile, and ear infections. Of these, the gastrointestinal segment is expected to experience significant growth due to the increasing prevalence of acute infectious diarrhea in children worldwide. The Asia-Pacific region is projected to hold the largest market share by 2035 due to the growing prevalence of infectious diseases, increasing antibiotic consumption, a rising population, and increasing healthcare expenditure.

While the market is expected to grow, certain factors may restrain its development. One significant concern is the development of antibiotic resistance, which poses a significant challenge to the effectiveness of antibiotics in treating infections. Additionally, an inadequate pipeline of antibiotics could hinder the market's growth. However, the discovery of advanced molecules and novel combination therapies to treat antibiotic-resistant microbial infections offers significant opportunities for the antibiotics market to expand and meet the evolving global demand.

shunculture

The facility's impact on penicillin production

Sandoz, a generic pharmaceuticals company based in Switzerland, opened a new antibiotic manufacturing facility in Kundl, Austria, in November 2023. The facility, which cost €150 million ($160.4 million) to build, is expected to strengthen the future of antibiotics manufacturing in Europe.

The facility includes automation and state-of-the-art technology for API manufacturing and finished dosage forms (FDFs). It is connected to the existing penicillin production facility and covers an additional area of 1875m². The expansion will support a double-digit increase in output capacity for penicillins.

The new facility focuses on bulk formulation and fill-finish activities for penicillins for global distribution. It will allow Sandoz to integrate all production steps into a single process in one location, resulting in increased capacity and supply reliability.

In addition to the facility in Austria, Sandoz is also investing €50 million ($60.7 million) for sterile API production at Palafolls, Spain. The company intends to discontinue the current manufacturing of oral APIs at the Les Franqueses site in Spain, which is slated for closure in 2024. The transfer of sterile API production from Kundl to the new Palafolls facility is scheduled for 2025.

shunculture

The cost of the facility

The Sandoz Antibiotic Manufacturing Facility in Kundl, Austria, was developed with an estimated investment of €150 million ($160.4 million). The facility includes automation and state-of-the-art technology for API manufacturing and finished dosage forms (FDFs). The project is part of Sandoz's plan to strengthen the future of antibiotics manufacturing in Europe.

In addition to the €150 million investment in the Kundl site, Sandoz also announced plans to invest more than €100 million in new manufacturing technology for the production of oral amoxicillin active pharmaceutical ingredient (API) at the same location. This brings the total investment in the Kundl site to €250 million.

Furthermore, Sandoz announced an additional investment of €50 million for sterile API production at Palafolls, Spain. This brings the total planned investment in the Sandoz antibiotics network across Europe to over €250 million.

The new facility in Kundl became operational in November 2023 and is the inaugural site to undergo the pilot process for the newly introduced global Minimized Risk of Antimicrobial Resistance (AMR) certification. The certification programme aims to validate responsible antibiotic manufacturing practices within the global supply chain.

The facility features a three-storey building connected to the existing penicillin production facility, expanding its footprint by 1,875 square metres. It focuses on bulk formulation and fill-finish activities for penicillin, intended for global distribution. The expansion will support a double-digit increase in output capacity for penicillins.

Frequently asked questions

Amoxicillin is manufactured in Kundl, Austria, at the Sandoz antibiotic manufacturing facility.

The facility was opened in November 2023 to support increased production capacity for finished dosage form (FDF) penicillin, the most widely used class of antibiotics worldwide.

The facility was developed with an estimated investment of €150 million ($160.4 million).

Written by
Reviewed by
Share this post
Print
Did this article help you?

Leave a comment