Dr Reddy’s Laboratories has received a Notice of Non-Compliance from the Pharmaceutical Drugs Directorate, Canada. The notice concerns the company’s Abbreviated New Drug Submission (ANDS) for Semaglutide injection, used to treat type 2 diabetes.
Source: Dr. Reddy’s Laboratories Limited Press Release (NSE Exchange Filings) | Published on Oct 29, 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 Dr Reddy’s Laboratories Limited (NSE Exchange Filings), the company received a Notice of Non-Compliance (NON) from the Pharmaceutical Drugs Directorate (PDD), Canada. The notice pertains to its Abbreviated New Drug Submission (ANDS) for Semaglutide injection, a drug formulation intended for diabetes management.
The NON was issued following the Canadian regulatory body's evaluation of the company’s submission. The communication indicates that certain elements within the application require clarification before further regulatory consideration.
Also read: Zydus Lifesciences Gets USFDA EIR for Baddi Plant
Dr Reddy’s Laboratories received a Notice of Non-Compliance from Canada’s Pharmaceutical Drugs Directorate.
The notice relates to its Abbreviated New Drug Submission for Semaglutide injection.
The company continues its regulatory submissions in global markets.
The Pharmaceutical Drugs Directorate of Canada oversees the authorisation and compliance of pharmaceutical products intended for the Canadian market. A Notice of Non-Compliance is typically issued when additional information or data is required to meet the regulatory standards under Health Canada’s guidelines.
Dr Reddy’s Laboratories will address the points raised by the authority as per regulatory procedures. The company’s existing operations and marketed products in Canada remain unaffected by the current notice.
Semaglutide injection, used in the management of type 2 diabetes mellitus, is an injectable glucagon-like peptide-1 receptor agonist (GLP-1 RA). The company had filed an ANDS to manufacture and market the formulation in Canada under the country’s generic drug approval framework.
Dr Reddy’s Laboratories Limited, headquartered in Hyderabad, India, operates in the global pharmaceutical industry with a diversified portfolio across generic formulations, active pharmaceutical ingredients (APIs), biosimilars, and over-the-counter products.
The company supplies medicines to more than 60 countries and has manufacturing facilities approved by regulatory agencies, including the USFDA, EMA, and Health Canada. Its product pipeline spans several therapeutic areas, including cardiovascular, gastrointestinal, oncology, and metabolic disorders.
Parameter | Detail |
Company | Dr Reddy’s Laboratories Limited |
Regulatory Body | Pharmaceutical Drugs Directorate, Canada |
Type of Communication | Notice of Non-Compliance (NON) |
Application Type | Abbreviated New Drug Submission (ANDS) |
Drug Name | Semaglutide Injection |
Therapeutic Category | Type 2 Diabetes Management |
Company Headquarters | Hyderabad, India |
Dr Reddy’s Laboratories continues to maintain active regulatory filings across major international markets. The issuance of the NON is part of the standard regulatory review process and is not uncommon in pharmaceutical submissions.
As of 29 October 2025, 15:30 PM IST, Dr Reddy’s Laboratories' share price on the National Stock Exchange (NSE) was ₹1,258.40, down ₹31.00 (−2.40%) from the previous close of ₹1,289.40.
Also Read: Ola Electric Receives CCPA Investigation Report and Hearing Date
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