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Cipla Ltd. Regulatory Filings 2019

Mar 31, 2019

59275_rns_2019-03-31_bcaff6af-060e-474c-9093-662c8f8aaf0f.pdf

Regulatory Filings

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31[st] March 2019

(1) BSE Ltd (2) National Stock Exchange of India Ltd Listing Department, Listing Department, Phiroze Jeejeebhoy Towers, Exchange Plaza, 5[th] floor, Dalal Street, Plot no. C/1, G Block, Mumbai - 400 001 Bandra Kurla Complex, Bandra (East), Mumbai - 400 051

Scrip Code: 500087

Scrip Code: CIPLA EQ

  • (3) SOCIETE DE LA BOURSE DE LUXEMBOURG Societe Anonyme 35A, Boulevard Joseph II

    • L-1840 Luxembourg

Dear Sirs,

Pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, the Company wishes to inform you that the US FDA conducted a product specific pre-approval (PAI) and Good Manufacturing Practices (GMP) inspection at its Kurkumbh plant from 11[th] March 2019 to 20[th] March 2019. The inspection covered 3 units at the plant. Post the conclusion of the inspection, the Company received 8 GMP observations. The Company also received 10 observations pertaining to the PAI for a novel technology product slated for approval beyond 2024. These observations are both product specific and GMP observations related to the manufacturing and quality processes. There are no data integrity (DI) observations. The Company is committed to addressing these observations and will submit its response to the agency within the stipulated time.

Kindly take the above information on record.

Thank you.

Yours faithfully, For Cipla Limited

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Rajendra Chopra Company Secretary

Cipla Ltd. Regd. Office Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai – 400 013 Phone +91 22 24826000 Fax +91 22 24826120 E-mail [email protected] Website www.cipla.com Corporate Identity Number L24239MH1935PLC002380