Summary of Commission Decision of 4 July 2025 relating to a proceeding under Article 101 of the Treaty on the Functioning of the European Union and Article 53 of the EEA Agreement (Case AT.40636 – SNBB) (notified under document number C(2025) 4363 final)
Date: 2025-07-04
Institutions: Directorate-General for Competition, European Commission
Subjects: EU competition policy, European Economic Area, cartel, control of restrictive practices, pharmaceutical industry, price agreement, sanction (EU), unlawful agreement








C_202600699EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2026/699


3.2.2026






Summary of Commission Decision
of 4 July 2025
         
relating to a proceeding under Article 101 of the Treaty on the Functioning of the European Union and Article 53 of the EEA Agreement
(Case AT.40636 – SNBB)


(notified under document number C(2025) 4363 final)


(Only the English version is authentic)
(Text with EEA relevance)
(C/2026/699)


On 4 July 2025, the Commission adopted a decision relating to a proceeding under Article 101 of the Treaty on the Functioning of the European Union and Article 53 of the EEA agreement. In accordance with the provisions of Article 30 of Council Regulation (EC) No 1/2003
          (1)
, the Commission herewith publishes the names of the addressees and the main content of the decision, including any penalty imposed, having regard to the legitimate interest of undertaking in the protection of their business secrets.

1.   INTRODUCTION









(1)


The case concerns a single and continuous infringement of Article 101(1) of the Treaty on the Functioning of the European Union and Article 53(1) of the EEA Agreement. The infringement consisted of bilateral and multilateral contacts regarding sales prices and the allocation of quotas (2) on the worldwide merchant market for N-Butylbromide Scopolamine/Hyoscine (‘SNBB’) (3), including the European Economic Area (‘EEA’).












(2)


SNBB is an Active Pharmaceutical Ingredient (‘API’) and an important input material for the production of the drug Buscopan and its generic versions. These are medications used in the treatment of motion sickness, abdominal cramps, and post-operative nausea and vomiting. SNBB is commonly extracted from the leaves of Duboisia trees, which are a natural source of SNBB.












(3)


The Decision is addressed to the following legal entities (together referred to as ‘Alchem’):






(a)


Alchem International Pvt. Ltd.,










(b)


Alchem International (H.K.) Limited.








2.   CASE DESCRIPTION

2.1.   Procedure









(4)


The Decision pursuant to Article 7 of Regulation (EC) No 1/2003 concerns an infringement which had as its object the prevention, restriction or distortion of competition for the supply of SNBB.












(5)


Following an immunity application by an SNBB supplier, not addressed by this Decision, on 15 April 2019 under the Leniency Notice (4), the Commission carried out unannounced inspections between 17 and 20 September 2019.












(6)


On 19 September 2019, another SNBB supplier applied for immunity or, in the alternative, for reduction of fines. The application was followed by a leniency application by another SNBB supplier on 29 October 2019.












(7)


On 20 October 2021, the Commission initiated proceedings pursuant to Article 2(1) of Regulation (EC) No 773/2004 (5) against Alchem International Pvt. Ltd. and the other six SNBB suppliers (‘the Parties’) with a view to engaging in settlement discussions with all of them under the Settlement Notice (6).












(8)


Between December 2021 and May 2023, settlement meetings took place between the Commission and the Parties.












(9)


On […], Alchem International Pvt. Ltd. informed the Commission that it would not submit a formal request to settle pursuant to Article 10a(2) of Regulation (EC) No 773/2004. The Commission has therefore continued the investigation into Alchem International Pvt. Ltd.’s conduct under the standard procedure in view of the adoption of a decision pursuant to Articles 7(1) and 23(2) of Regulation (EC) No 1/2003.












(10)


On 19 October 2023, the Commission adopted the Settlement Decision pursuant to Article 7(1) and Article 23(2) of Regulation (EC) No 1/2003 addressed to the other six SNBB suppliers and finding them liable for an infringement of Article 101(1) of the Treaty on the Functioning of the European Union and Article 53(1) of the EEA Agreement.












(11)


On 13 June 2024, the Commission initiated proceedings pursuant to 2(1) of Regulation (EC) No 773/2004 against Alchem International (H.K.) Limited and adopted a Statement of Objections (‘SO’) addressed to Alchem. The Commission offered Alchem the possibility to provide observations on the SO.












(12)


On 23 August 2024, Alchem received access to the Commission's investigation file via a confidentiality ring and made use of its right to access corporate leniency statements via eLeniency.












(13)


On 4 November 2024, Alchem submitted its observations on the SO. Alchem did not request an oral hearing to develop its arguments.












(14)


On 16 May 2025, the Commission sent a Letter of Facts to Alchem.












(15)


On 30 May 2025, Alchem submitted its observations on the Letter of Facts.












(16)


The Advisory Committee on Restrictive Practices and Dominant Positions issued a favourable opinion on 2 July 2025.












(17)


On 2 July 2025, the Hearing Officer issued a final report.




2.2.   Summary of the infringement









(18)


The conduct that is the subject of these proceedings consisted of bilateral and multilateral contacts involving Alchem and the other SNBB suppliers regarding sales prices and the allocation of quotas on the worldwide merchant market for SNBB. The objective of the conduct was to coordinate and agree on the level of the minimum sales price of SNBB for customers (i.e. distributors and generic drug manufacturers) worldwide and on the allocation of quotas among the SNBB producers to stabilise the world market price and to prevent it from falling.












(19)


Alchem coordinated its future pricing and market behaviour through multilateral and bilateral contacts with the other SNBB suppliers. The contacts concerned: (i) the fixing of the level of the minimum sales price of SNBB charged to customers (i.e. distributors and generic drug manufacturers); (ii) the allocation of yearly quotas among the SNBB producers and; (iii) the exchange of commercially sensitive information on the SNBB sales prices and of information about the following factors influencing the sales prices of SNBB: the evaluation of market trends based on the expected harvest of leaves from the Duboisia trees, the supply situation and the development of production volumes of the SNBB producers.












(20)


The infringement covered by the Decision was EEA-wide.




2.3.   Addressees and duration









(21)


This Decision is addressed to:






(a)


Alchem International Pvt. Ltd., headquartered at 201, Empire Plaza, Mehrauli – Gurgaon Road, Sultanpur New Delhi-110 030, India;










(b)


Alchem International (H.K.) Limited, headquartered at Rm 1705-06 The L. Plaza. 367-375 Queen’s Rd Central, Hong Kong.
















(22)


Overall, the conduct lasted from 1 November 2005 to 17 September 2019. Alchem’s participation in the conduct lasted from 1 November 2005 to 12 February 2018.




2.4.   Remedies and fines

2.4.1.   Remedies









(23)


The fine to be imposed on Alchem for the conduct is calculated on the basis of the principles laid out in the 2006 Guidelines on the method of setting fines imposed pursuant to Article 23(2)(a) of Regulation No 1/2003 (7).




2.4.2.   Basic amount of the fine









(24)


In setting the fine, the Commission took into account the annual average of Alchem’s sales of SNBB delivered in the EEA during the entire infringement period.












(25)


In addition, the Commission took into account the fact that cartels are, by their very nature, among the most harmful restrictions of competition, the duration of the infringement, its multifaceted nature, the fact that the infringement covered the EEA and an additional amount to deter undertakings from entering into such practices.




2.4.3.   Adjustments to the basic amount

2.4.3.1.   Aggravating circumstances









(26)


The Commission did not apply any aggravating circumstances.




2.4.3.2.   Mitigating circumstances









(27)


The Commission did not apply any mitigating circumstances.




2.4.4.   Specific increase for deterrence









(28)


The Commission did not apply a deterrence multiplier.




2.4.5.   Application of the 10 % turnover limit









(29)


The fine imposed on Alchem did not exceed 10 % of its total turnover relating to the business year preceding the date of the Commission’s decision.




2.4.6.   Application of the 2006 Leniency Notice: reduction of fines









(30)


Alchem did not submit an application for a reduction of fines in cartel cases and therefore no leniency reduction was granted.




3.   CONCLUSION









(31)


In light of the above, the Decision concludes that the final amount of the fine imposed on Alchem pursuant to Article 23(2) of Regulation No 1/2003 amounts in total to EUR 489 000. In particular, the Commission imposed on Alchem International Pvt. Ltd. EUR 489 000, of which Alchem International (H.K.) Limited is held jointly and severally liable for the amount of EUR 252 000.






(1)  Council Regulation (EC) No 1/2003 of 16 December 2002 on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty (OJ L 1, 4.1.2003, p. 1, ELI: http://data.europa.eu/eli/reg/2003/1/oj) (hereafter, ‘Regulation No 1/2003’).

(2)  The quotas were allocated per SNBB producer.

(3)  SNBB is the acronym often used in the industry. The product is also known as Butylscopolamine bromide, Scopolamine butylbromide and Hyoscine butylbromide.

(4)  Commission notice on Immunity from fines and reduction of fines in cartel cases (OJ C 298, 8.12.2006, p. 17).

(5)  Commission Regulation (EC) No 773/2004 of 7 April 2004 relating to the conduct of proceedings by the Commission pursuant to Articles 81 and 82 of the EC Treaty (OJ L 123, 27.4.2004, p. 18). Regulation as amended by Commission Regulation (EC) No 622/2008 (OJ L 171, 1.7.2008, p. 3) and Commission Regulation (EU) 2015/1348 (OJ L 208, 5.8.2015, p. 3).

(6)  Commission Notice on the conduct of settlement procedures in view of the adoption of Decisions pursuant to Article 7 and Article 23 of Council Regulation (EC) No 1/2003 in cartel cases (OJ C 167, 2.7.2008, p. 1)

(7)  Guidelines on the method of setting fines imposed pursuant to Article 23(2)(a) of Regulation (EC) No 1/2003 (OJ C 210, 1.9.2006, p. 2).


ELI: http://data.europa.eu/eli/C/2026/699/oj
ISSN 1977-091X (electronic edition)