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Dr Reddy’s Gets Non-Compliance Notice from Canada

Synopsis:


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.

Dr. Reddy’s Laboratories Limited News Today

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

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1203-47.90 (-3.82 %)

Updated - 30 October 2025
1204.00day high
DAY HIGH
1180.90day low
DAY LOW
2283916
VOLUME (BSE)

Key Takeaway

  • 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.

Regulatory Background

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.

Company Overview

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.

Regulatory Filing Details

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

Operational Context

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.

Dr Reddy’s Laboratories Share Price Performance

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.

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