NSEGeneral Updates1d ago · 31 Aug 2026, 12:58 pm

General Updates

BALAXI PHARMACEUTICALS LIMITED · BALAXI

✦ AI Summary▲ PositiveExpansion

Balaxi Pharmaceuticals Limited has received WHO-GMP Certification for its first pharmaceutical formulation manufacturing facility, a significant milestone in the company's journey towards establishing its own manufacturing capabilities.

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Earnings Impact8/10
Growth Catalyst9/10
Governance Concern1/10
Regulatory Risk2/10
Balance Sheet Risk1/10
Liquidity Impact9/10
Market Sentiment8/10

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Full Announcement

Balaxi Pharmaceuticals Limited has informed the Exchange about the receipt of WHO-GMP Certification for Company's Pharmaceutical Formulation Manufacturing Facility.

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BALAXI_31082026125652_NSE_Announcement_WHO_GMP_Approval_31082026.pdf

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Date: 31st August, 2026 Listing Department, National Stock Exchange of India Limited Exchange Plaza, Plot No C-1, Block G, Bandra Kurla Complex, Bandra (E), Mumbai – 400051 NSE Symbol: BALAXI Subject: Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 – Receipt of WHO-GMP Certification for Company's Pharmaceutical Formulation Manufacturing Facility Dear Sir/Madam, Pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, we are pleased to inform you that Balaxi Pharmaceuticals Limited ("Company") has received the WHO-GMP (Good Manufacturing Practices) Certification for its first pharmaceutical formulation manufacturing facility located at Jadcherla, Hyderabad, Telangana. The WHO-GMP Certification has been issued by the Licensing Authority, Government of Telangana, following the inspection of the Company's manufacturing facility conducted on 14th July, 2026. The certificate is dated 27th August, 2026 and is valid up to 26th August, 2029. The receipt of the WHO-GMP Certification marks a significant milestone in the Company's journey towards establishing its own manufacturing capabilities and further strengthens its quality and manufacturing credentials. The Company has commenced manufacturing of its initially approved products at the facility as it awaits approval for some additional products and, going forward, will progressively add more products to strengthen and expand its product portfolio for its target international markets, subject to applicable regulatory requirements and approvals. The requisite details as prescribed under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, are enclosed herewith as Annexure A. We request you to kindly take the above information on record. The same will also be available on the Company’s website at www.balaxipharma.in Thanking You. Yours faithfully, For Balaxi Pharmaceuticals Limited Aman Purohit (Company Secretary & Compliance Officer) ICSI Membership No.: A59345 (Encl: As above) Annexure A Disclosure pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 Sr. No. Particulars Brief Details 1. Name of the authority Licensing Authority, Government of Telangana The Company has received WHO-GMP Certification for its first pharmaceutical formulation manufacturing facility located at Nature and details of Jadcherla, Hyderabad, Telangana, following the inspection the action(s) taken, 2. conducted by the Licensing Authority, Government of Telangana. initiated or order(s) The certification confirms compliance of the site with Good passed Manufacturing Practices for the certified dosage form, categories and activities. Date of receipt of direction or order, including any ad- 3. interim or interim 27th August, 2026 orders, or any other communication from the authority Details of the violation(s) / 4. contravention(s) Not Applicable committed or alleged to be committed The receipt of WHO-GMP Certification is a significant milestone for Impact on financial, the Company and strengthens its manufacturing and quality operation or other credentials. The Company intends to commence manufacturing of its activities of the listed 5. initial set of products at the facility and progressively add more entity, quantifiable in products to strengthen and expand its product portfolio for its target monetary terms to the international markets. The Company does not anticipate any adverse extent possible impact on its existing business operations.