Description

NATCO Pharma clarifies ongoing litigation with no current material impact, while Cipla addresses USFDA Form 483 observations at partner facility Pharmathen manufacturing Lanreotide Injection.

Summary

Two pharmaceutical companies provided clarifications under Regulation 30 of SEBI (LODR) Regulations, 2015. NATCO Pharma Limited responded to BSE queries regarding news articles about ongoing litigation, confirming the matter is pending with no material financial impact currently. Cipla Limited clarified media reports about USFDA Form 483 inspectional observations at its supply partner Pharmathen International S.A.’s Greece facility, which manufactures Lanreotide Injection for Cipla’s US subsidiary.

Key Points

  • NATCO Pharma confirmed ongoing litigation proceedings with outcome awaiting, no material financial impact as of now
  • NATCO stated it has consistently made required disclosures under Regulation 30 of SEBI (LODR) Regulations, 2015
  • Cipla’s supply partner Pharmathen underwent USFDA inspection at Rodopi, Greece facility from November 10-21, 2025
  • Pharmathen received nine (9) inspectional observations in Form 483 issued by USFDA
  • Pharmathen manufactures Lanreotide Injection for Cipla USA Inc., a wholly owned subsidiary of Cipla Limited
  • Form 483 became public on January 7, 2026
  • Cipla is currently evaluating the impact of USFDA observations

Regulatory Changes

No regulatory changes announced. Both companies filed clarifications in response to stock exchange queries under existing Regulation 30(11) of SEBI (LODR) Regulations, 2015 regarding news articles and media reports.

Compliance Requirements

  • Companies must provide clarifications when stock exchanges seek information about news articles that may impact trading
  • Companies must disclose material information and explain sequence of events from start of negotiations/events
  • Companies must confirm awareness of any undisclosed information that could explain trading movements
  • Companies must assess and disclose material impact of news articles on operations
  • Cipla committed to keep stock exchanges informed of any updates with material impact per regulatory requirements

Important Dates

  • November 10-21, 2025: USFDA inspection conducted at Pharmathen’s Rodopi, Greece facility
  • January 7, 2026: BSE issued query letter to NATCO Pharma (Ref: L/SURV/ONL/RV/SG/ (2025-2026)/ 120)
  • January 7, 2026: USFDA Form 483 for Pharmathen became public
  • January 7, 2026: Both companies filed clarifications with stock exchanges

Impact Assessment

NATCO Pharma: Limited immediate impact as litigation outcome is pending and company states no material financial impact currently. Market monitoring may continue until litigation concludes.

Cipla: Moderate potential impact depending on severity of nine USFDA observations at partner facility. Since Pharmathen manufactures Lanreotide Injection for US market through Cipla USA Inc., observations could affect product supply, regulatory approvals, or require remediation actions. Cipla is evaluating impact, indicating uncertainty about operational and financial implications. USFDA Form 483 observations can range from minor procedural issues to significant manufacturing compliance problems requiring facility improvements or product holds.

Impact Justification

NATCO's ongoing litigation outcome pending with no current material impact. Cipla's supply partner received 9 USFDA observations requiring evaluation, potentially affecting Lanreotide Injection supply to US market.