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Medicamen Biotech Ltd. Regulatory Filings 2024

Apr 26, 2024

61898_rns_2024-04-26_8e762bbc-ca17-460c-a66a-66afb5031571.pdf

Regulatory Filings

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Ref: STEX/Announcement/2024-25

Date: 26.04.2024

BSE Limited Phiroze Jeejeebhoy Towers, Dalal Street, Mumbai – 400001

National Stock Exchange of India Limited Exchange Plaza, Bandra Kurla complex Bandra(E) Mumbai- 400051

Code No: 531146 Symbol: MEDICAMEQ

Sub: Completion of US FDA Inspection at the Oncology Formulation facility of Medicamen Biotech Limited at Hardwar facility.

Dear Sir/ Ma’am,

Pursuant to Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, this is to inform you that:

The United States Food and Drug Administration (US FDA) inspected the Oncology Formulation facility of Medicamen Biotech Limited located at Plot No. 84 & 85, Sector-6A, IIE, Sidcul, BHEL, Ranipur, Haridwar- 249403 from April 17, 2024 and concluded on today i.e. April 26, 2024 at 4:00 PM.

The inspection closed with 6 procedural observations which were complied with proactively and acknowledged by the auditor. However, the final approval (EIR) is expected after submission of formal response to FDA.

This is for your information and records.

Thanking You

Yours truly,

For Medicamen Biotech Limited

PARUL Digitally signed by PARUL CHOUD CHOUDHARY Date: 2024.04.26 HARY 16:01:30 +05'30' Parul Choudhary Company Secretary ACS: 44157

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