Unichem Laboratories , a prominent pharmaceutical company, has received a substantial demand notice from the European Commission related to a long-standing Perindopril case. The notice, amounting to €19.49 million, stems from allegations of breaching EU competition law in a 2005 patent dispute settlement with the Servier Group.

Demand Notice Details

The European Commission's demand breaks down as follows:

Unichem has already made a partial payment through its wholly-owned subsidiary, remitting €2,791,262.76 in installments. This leaves a balance of €16,695,746.29 still payable to the European Commission.

Financial Impact and Company Response

The demand notice presents significant financial implications for Unichem Laboratories:

1. The company had previously made provisions for the principal amount of €13,968,773.00 in its books of account.
2. The interest component of €5,518,236.05 will need to be provided for in the company's financial statements.

Unichem Laboratories is currently evaluating its legal options in consultation with its law firm. The company's management is expected to act based on the advice received, indicating a potential challenge to the demand or exploration of settlement options.

Background of the Case

The demand notice is related to allegations that Unichem and its wholly-owned subsidiary, Niche Generics Ltd, violated EU competition law. The case revolves around a settlement agreement reached in 2005 with the Servier Group concerning a Perindopril patent dispute.

Regulatory Compliance

In compliance with SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, Unichem Laboratories has duly informed the National Stock Exchange of India Limited and BSE Limited about this development. The company's transparency in disclosing this information underscores its commitment to regulatory compliance and shareholder communication.

As this situation unfolds, stakeholders and industry observers will be keenly watching Unichem Laboratories' next steps in addressing this significant financial demand from the European Commission.

Unichem Laboratories , a prominent pharmaceutical company, has recently concluded a significant regulatory milestone with the United States Food and Drug Administration (USFDA). The company announced that it has received the Establishment Inspection Report (EIR) following a voluntary inspection of its Roha API facility.

Inspection Details

The inspection took place from June 16 to June 20. Unichem Laboratories confirmed that the USFDA has classified the inspection as Voluntary Action Initiated (VAI).

Regulatory Implications

The receipt of the EIR and the VAI classification are important developments for Unichem Laboratories. A VAI classification typically indicates that while the FDA found some objectionable conditions during the inspection, these issues do not meet the threshold for regulatory or enforcement action. Instead, the company is expected to address these voluntarily.

Company's Response

In its communication to the stock exchanges, Unichem Laboratories stated, "We wish to inform that the USFDA has classified the inspection as Voluntary Action Initiated ("VAI") and we have received the Establishment Inspection Report ("EIR")." This statement was made by Pradeep Bhandari, Head – Legal & Company Secretary of Unichem Laboratories.

Facility Information

The inspection pertained to Unichem's Roha API facility. API stands for Active Pharmaceutical Ingredient, which is the biologically active component in a drug product. The Roha facility is likely a crucial part of Unichem's manufacturing operations, producing key ingredients for various pharmaceutical products.

Conclusion

Unichem Laboratories continues to demonstrate its commitment to regulatory compliance and quality standards in its pharmaceutical manufacturing processes. The company's proactive approach in voluntarily undergoing USFDA inspections reflects its focus on maintaining high standards in its operations.