ARTICLE
29 July 2025

European Commission Fines Alchem In First Cartel Case Involving A Pharmaceutical API

AO
A&O Shearman

Contributor

A&O Shearman was formed in 2024 via the merger of two historic firms, Allen & Overy and Shearman & Sterling. With nearly 4,000 lawyers globally, we are equally fluent in English law, U.S. law and the laws of the world’s most dynamic markets. This combination creates a new kind of law firm, one built to achieve unparalleled outcomes for our clients on their most complex, multijurisdictional matters – everywhere in the world. A firm that advises at the forefront of the forces changing the current of global business and that is unrivalled in its global strength. Our clients benefit from the collective experience of teams who work with many of the world’s most influential companies and institutions, and have a history of precedent-setting innovations. Together our lawyers advise more than a third of NYSE-listed businesses, a fifth of the NASDAQ and a notable proportion of the London Stock Exchange, the Euronext, Euronext Paris and the Tokyo and Hong Kong Stock Exchanges.
On 4 July 2025, the EC fined Alchem and its subsidiary EUR 489,000 for their role in a long-running cartel concerning the active pharmaceutical ingredient SNBB, used in the production of Buscopan and its generics
United States Food, Drugs, Healthcare, Life Sciences

Executive summary

On 4 July 2025, the EC fined Alchem and its subsidiary EUR 489,000 for their role in a long-running cartel concerning the active pharmaceutical ingredient SNBB, used in the production of Buscopan and its generics. This marks the EC's first cartel case in the pharmaceutical sector involving an API. The case also highlights the EC's continued scrutiny of the pharmaceutical industry and its willingness to pursue hybrid enforcement procedures.

A case of horizontal collusion in the supply of SNBB

According to the press release of the European Commission (EC), for 12 years, Alchem International Pvt. Ltd. and its subsidiary Alchem International (H.K.) Limited (together, Alchem) coordinated and agreed with other producers of the active pharmaceutical ingredient (API) N-Butylbromide Scopolamine/Hyoscine (SNBB) to fix the minimum sales prices for SNBB charged to distributors and generic drug manufacturers, and to allocate yearly sales quotas among them. Alchem also exchanged commercially sensitive information on (factors influencing) SNBB sales prices. The EC's investigation revealed that Alchem participated in this conduct, which covered the entire EEA, from 1 November 2005 to 12 February 2018.

A hybrid enforcement procedure

Despite a decreased appetite to pursue hybrid settlement cases, the EC's investigation followed such an enforcement route. Indeed, in October 2023, the EC secured a settlement in relation to the same cartel with six other pharmaceutical companies – namely, Alkaloids of Australia, Alkaloids Corporation, Boehringer, Transo-Pharm, Linnea, and C2 PHARMA – imposing a total fine of EUR 13.4 million. In return for a 10% reduction of their respective fines, these companies acknowledged their participation in the infringement and accepted liability for it. Moreover, Transo-Pharm and Linnea benefited from 50% and 30% reductions of their respective fines in return for their cooperation with the EC's investigation under the leniency programme. C2 PHARMA avoided a fine as it revealed the existence of the cartel (see the EC's press release and settlement decision).

Whilst Alchem was also involved in the EC's investigation, it opted not to settle the case. In line with its standard practice, the EC pursued the investigation against Alchem under the ordinary enforcement procedure – issuing a statement of objections in June 2024 and concluding its investigation with the adoption of a full infringement decision in July 2025.

Continued EC scrutiny of the pharmaceutical sector

As emphasized by the EC, the SNBB case represents the first instance of a cartel in the pharmaceutical industry and in relation to an API to be sanctioned by the EC. It reflects a broader global trend of heightened antitrust scrutiny in the pharmaceutical sector. In announcing the decision, Executive Vice-President Teresa Ribera observed that the EC's decision "underscores the crucial role of competition as the key to unlocking affordable access to essential medicines". This case signals the EC's continued focus on upstream pharmaceutical markets and its readiness to pursue enforcement where pricing coordination is suspected.

Key Takeaways

  • This is the first EC cartel case involving an API.
  • The case underscores the EC's continued focus on the pharmaceutical sector.
  • The hybrid enforcement approach confirms the EC's persistent willingness to pursue both settlement and ordinary procedures in parallel, despite its declared decreased propensity to do so.
  • Companies in the life sciences sector should remain vigilant about pricing coordination and information exchanges, even for upstream inputs like APIs.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More