BAJAJ BROKING
The U.S. FDA has classified Sun Pharma’s Halol plant as “Official Action Indicated” (OAI) following eight observations from a June inspection, keeping it under import alert.
Source: Sun Pharma Press Release (NSE Exchange Fillings) | Published on Sept 10, 2025
Disclaimer: This content has been published for informational purposes only. Bajaj Broking is not affiliated with, nor does it endorse or assume any responsibility for, the source material. Readers are advised to consult the original publication for complete and accurate context.
As quoted in the press release from Sun Pharma (NSE Exchange filings), the company's production plant in Gujarat was labelled "Official Action Indicated" following a period of inspection during 2-13 June 2025. The classification indicates that there was non-compliance with current good manufacturing practices, and corrective action is needed.
Also read: SMBC Sells 1.65% in Kotak Mahindra Bank for ₹6,166 Crore Through Block Deal
The Halol plant has been placed under “OAI,” confirming compliance gaps.
Import alert continues, with limited exemptions for shortage-related products.
Sun Pharma share price stands at ₹1,592 per share on the BSE as of 10 Sep 2025 at 15:30 PM IST.
The OAI designation states that the Halol site may not be able to ship products freely into the U.S. market until compliance issues are resolved. The U.S. already has an import alert, so shipments still cannot be made, except for essential medicines in limited situations, and the inspection noted eight lapses in practice, showing the level of concern from the regulator.
Item | Details |
FDA Classification | Official Action Indicated (OAI) |
Inspection Period | 2–13 June 2025 |
Number of Observations | Eight |
Export Status to U.S. | Import alert in place (restricted except shortage exemptions) |
Sun Pharma share price (BSE) | ₹1,592 per share (10 Sep 2025, 17:30 IST) |
The Halol plant is a critical part of Sun Pharma's global supply chain and has recently been inspected several times. The continued issuance of regulatory observations has generated borrowed regulatory concern over the facility. Based upon the OAI classification, the plant will need to improve before it regains the regulator's confidence.
The latest Sun Pharma share price of ₹1,592 gives you a market view of how sentiments trailing this facility are currently. As you follow along (as investor), this news suggests that you should monitor not only compliance, but any regulatory updates related to this plant, as it will likely affect future operational impact.
Also read: Sterling and Wilson Bags ₹415 Crore LoA for 300 MW Solar Project in Rajasthan
Share this article:
Disclaimer :
The information on this website is provided on "AS IS" basis. Bajaj Broking (BFSL) does not warrant the accuracy of the information given herein, either expressly or impliedly, for any particular purpose and expressly disclaims any warranties of merchantability or suitability for any particular purpose. While BFSL strives to ensure accuracy, it does not guarantee the completeness, reliability, or timeliness of the information. Users are advised to independently verify details and stay updated with any changes.
The information provided on this website is for general informational purposes only and is subject to change without prior notice. BFSL shall not be responsible for any consequences arising from reliance on the information provided herein and shall not be held responsible for all or any actions that may subsequently result in any loss, damage and or liability. Interest rates, fees, and charges etc., are revised from time to time, for the latest details please refer to our Pricing page.
Neither the information, nor any opinion contained in this website constitutes a solicitation or offer by BFSL or its affiliates to buy or sell any securities, futures, options or other financial instruments or provide any investment advice or service.
BFSL is acting as distributor for non-broking products/ services such as IPO, Mutual Fund, Insurance, PMS, and NPS. These are not Exchange Traded Products. For more details on risk factors, terms and conditions please read the sales brochure carefully before investing.
Investments in the securities market are subject to market risk, read all related documents carefully before investing. This content is for educational purposes only. Securities quoted are exemplary and not recommendatory.
For more disclaimer, check here : https://www.bajajbroking.in/disclaimer
Level up your stock market experience: Download the Bajaj Broking App for effortless investing and trading