AstraZeneca Pharma India Ltd. — Regulatory Filings 2021

Mar 10, 2021

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March 10, 2021

The Manager- Listing

BSE Limited

Corporate Relationship Dept., 5[th] Floor, New Trading Ring Rotunda Building, P J Towers, Dalal Street, Fort, Mumbai - 400001

The Manager- Listing National Stock Exchange of India Limited

Exchange plaza, 5[th] Floor, Plot No. C/1, G Block Bandra –Kurla Complex, Bandra (E), Mumbai - 400051

Dear Sir(s),

Sub: AstraZeneca Pharma India Limited receives Import and Market Permission in Form CT-20 (Subsequent New Drug Approval) from the Drugs Controller General of India for Osimertinib 40mg/80mg film coated tablets (Tagrisso[TM] )

This is to inform that AstraZeneca Pharma India Limited has received Import and Market Permission in Form CT-20 (Subsequent New Drug Approval) from the Drugs Controller General of India for Osimertinib 40mg/80mg film coated tablets (Tagrisso[TM] ).

Osimertinib 40mg/80mg film coated tablets as monotherapy is now approved for additional indication for the adjuvant treatment after complete tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.

The receipt of this permission paves way for the launch of Osimertinib 40mg/80mg film coated tablets into a new disease area in India, subject to the receipt of related statutory approvals and licenses.

We request you to kindly take the same on record.

For AstraZeneca Pharma India Limited

PRATAP Digitally signed by RUDRA PRATAP RUDRA BHUVANAG BHUVANAGIRI Date: 2021.03.10 IRI 16:04:00 +05'30'

Pratap Rudra Company Secretary & Legal Counsel

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