NSEGeneral Updates1d ago · 31 Aug 2026, 12:58 pm
General Updates
BALAXI PHARMACEUTICALS LIMITED · BALAXI
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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.