BSECompany Update4d ago · 5 Nov 2026, 02:40 pm

Intimation for receipt of Establishment Inspection Report from US FDA by Innoxel Lifesciences Pvt Ltd., a subsidiary company of Bharat Parenterals Limited.

Bharat Parenterals Ltd · 541096

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Bharat Parenterals Ltd's subsidiary Innoxel Lifesciences receives Establishment Inspection Report (EIR) from USFDA for unannounced Pre-Approval Inspection of injectable product facility in Vadodara, Gujarat.

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Earnings Impact8/10
Growth Catalyst6/10
Governance Concern2/10
Regulatory Risk4/10
Balance Sheet Risk1/10
Liquidity Impact9/10
Market Sentiment9/10

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Bharat Parenterals Ltd - 541096 - Announcement under Regulation 30 (LODR)-Press Release / Media Release

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Date: November 05, 2026 BSE Limited Phiroze Jeejeebhoy Towers, Dalal Street, Fort, Mumbai –400001 Scrip Code: 541096 Sub: Receipt of Establishment Inspection Report (EIR) from the USFDA by Innoxel Lifesciences Private Limited, Subsidiary of Bharat Parenterals Limited Ref: Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, and our intimation dated April 21, 2026 Dear Sir/Madam, In continuation of our intimation dated April 21, 2026, and pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, we wish to inform you that Innoxel Lifesciences Private Limited ("Innoxel"), a subsidiary of the Company, has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA), vide its letter dated November 4, 2026, for the unannounced PAI (Pre-Approval Inspection) of the Injectable Product at its finished dosage manufacturing facility in Vadodara, Gujarat. The inspection was conducted from April 13, 2026 to April 20, 2026, and included product-specific coverage of a general injectable product. The U.S FDA has completed its assessment of the EIR and Innoxel's written responses, has closed the inspection, and considers the facility ready to support commercial operations of the subject product. A copy of the Press Release being issued in this regard is enclosed herewith. The Company remains committed to always maintaining the highest standards of quality and regulatory compliance. Kindly take the above on your record and acknowledge receipt of the same. Thanking You. For, Bharat Parenterals Limited Sharmin Soni Company Secretary & Compliance Officer ICSI Membership Number: A-75694 Encl: Press Release Press Release Bharat Parenterals Limited Vadodara, November 5, 2026 Innoxel Lifesciences Receives Establishment Inspection Report (EIR) from USFDA for April 2026 Unannounced Pre-Approval Inspection Facility found ready to support commercial operations of a general injectable product Bharat Parenterals Limited (BSE: 541096) is pleased to announce that its subsidiary, Innoxel Lifesciences Private Limited has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for the unannounced PAI (Pre-Approval Inspection) of the Injectable Product at its finished dosage manufacturing facility in Vadodara, Gujarat. The inspection, conducted from April 13th to 20th 2026, included product-specific coverage of a general injectable product. The USFDA has completed its assessment of the EIR and Innoxel's written responses, closed the inspection, and confirmed that it considers the facility ready to support commercial operations of the subject product, with no further questions. This is the second EIR received by the Vadodara facility, following the EIR issued in July 2025. The site also received an EU-GMP certificate covering all four of its manufacturing lines in March 2026, following an inspection by Belgium's Federal Agency for Medicines and Health Products (FAMHP) with zero critical and zero major observations. In October 2026, Innoxel commenced commercial supply to the United States with the launch of its first contract manufacturing (CMO) product by its sponsor partner. Commenting on the development, Mr. Bhahim Desai, Director – Strategy & Investor Relations, Bharat Parenterals Limited, said: "Closure of an unannounced USFDA Pre-Approval Inspection with an EIR, coming within weeks of our first commercial launch in the United States, is a strong validation of the quality systems at Innoxel. Being found inspection-ready on any given day is what our partners expect from a regulated-market CDMO, and this outcome, alongside our EU-GMP certification strengthens our position as we scale our complex injectables portfolio and partnerships for the United States and European markets." About Bharat Parenterals Limited Bharat Parenterals Limited is a Gujarat-based pharmaceutical company listed on BSE Limited, engaged in the manufacturing and marketing of quality pharmaceutical formulations across domestic and international markets, with exports to over 40 countries. Through its subsidiary Innoxel Lifesciences, the group is building a presence in complex and specialty injectables for regulated markets. About Innoxel Lifesciences Private Limited Innoxel Lifesciences Private Limited is a subsidiary of Bharat Parenterals Limited and a contract development and manufacturing organization (CDMO) focused on complex and specialty generic injectables for regulated markets. Its finished dosage facility in Vadodara, Gujarat holds an EIR from the USFDA and an EU-GMP certificate covering all four of its manufacturing lines. Safe Harbour Statement This press release may contain forward-looking statements based on current expectations of the management of Bharat Parenterals Limited. Such statements are subject to risks and uncertainties, including regulatory developments, market conditions and other factors beyond the Company's control, which may cause actual results to differ materially. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. For further information, please contact: Investor Relations, Bharat Parenterals Limited **************************************************