Description

NATCO Pharma provides clarification on ongoing litigation news, while Cipla addresses USFDA Form 483 inspectional observations at supply partner Pharmathen's Greece facility.

Summary

BSE sought clarifications from two pharmaceutical companies regarding news articles. NATCO Pharma Limited (Scrip Code: 524816) clarified that ongoing litigation mentioned in Economic Times is awaiting outcome with no current material financial impact. Cipla Limited (Scrip Code: 500087) disclosed that its supply partner Pharmathen International S.A. in Greece received 9 USFDA inspectional observations in Form 483 following inspection from November 10-21, 2025, affecting Lanreotide Injection manufacturing for Cipla USA Inc.

Key Points

  • NATCO Pharma confirmed ongoing litigation mentioned in news is continuing for several months with outcome pending
  • NATCO states no material financial impact as of current date and will inform exchanges upon litigation outcome based on materiality
  • Cipla’s supply partner Pharmathen received 9 USFDA Form 483 observations after inspection at Rodopi, Greece facility
  • USFDA inspection at Pharmathen conducted from November 10-21, 2025; Form 483 became public January 7, 2026
  • Pharmathen manufactures Lanreotide Injection for Cipla USA Inc., a wholly owned Cipla subsidiary
  • Cipla is evaluating impact and will provide updates if material impact identified
  • Both companies affirm adherence to Regulation 30 of SEBI LODR Regulations 2015

Regulatory Changes

No new regulatory changes introduced. Both circulars represent compliance with existing SEBI LODR Regulation 30(11) requirements for clarification on news items and material events.

Compliance Requirements

  • Companies must provide clarifications on news articles when requested by stock exchanges under Regulation 30 of SEBI LODR Regulations 2015
  • Disclosure of sequence of events, reasons for trading movements, and material impact assessment required
  • Companies must confirm whether undisclosed information exists that could explain trading movements
  • Ongoing obligation to update exchanges on material developments arising from disclosed events

Important Dates

  • January 7, 2026: BSE letter requesting clarification issued
  • January 7, 2026: Both companies submitted clarifications
  • January 7, 2026: USFDA Form 483 for Pharmathen became public
  • November 10-21, 2025: USFDA inspection period at Pharmathen Greece facility
  • Ongoing: NATCO litigation outcome awaited; Cipla impact evaluation in progress

Impact Assessment

NATCO Pharma: Medium impact - Ongoing litigation creates uncertainty but company confirms no current material financial impact. Market impact depends on eventual litigation outcome which remains undisclosed. Stock may experience volatility based on news speculation until resolution.

Cipla: Medium-to-high impact potential - USFDA Form 483 observations at supply partner facility could affect Lanreotide Injection supply chain. Nine observations indicate significant compliance issues requiring remediation. Potential impacts include manufacturing delays, supply disruptions, or warning letter if responses inadequate. Cipla’s evaluation ongoing; actual impact depends on observation severity and remediation timeline. Investors should monitor for further updates on material impact determination.

Impact Justification

NATCO's ongoing litigation has uncertain financial impact pending outcome. Cipla's supply partner received 9 USFDA observations requiring evaluation of impact on Lanreotide Injection manufacturing.