10 months ago
Dr Reddy's Stock Dips Amid Health Canada's Non-Compliance Notice for Semaglutide
Imagine a company wants to sell a copy of a popular medicine.
They need to ask the government for permission, like filling out a special form.
Dr. Reddy's wanted to sell a copy of a weight-loss drug called Semaglutide in Canada.
They sent in a shortened application because they are using another company's research.
However, the Canadian health authorities said 'not yet' and issued a notice that the application isn't quite right.
Because of this, the company's stock price went down.
This drug is important for the company, and they hoped to be one of the first to launch it in many places.
Dr Reddy's stock fell 4% on Thursday.
The decline followed a notice of non-compliance from Health Canada for its ANDA of Semaglutide.
Semaglutide is a weight loss drug and a peptide.
An ANDA is a shortened application for a generic drug, relying on innovator research.
The non-compliance notice from Health Canada suggests the application requires further details or did not meet approval standards for this specific molecule.
- Who
- Dr Reddy's Laboratories, Health Canada
- What
- Dr Reddy's stock dropped after Health Canada issued a notice of non-compliance for its Abbreviated New Drug Application (ANDA) for the weight loss drug Semaglutide.
- Where
- Canada (Health Canada)
- When
- Thursday (specific date not provided, but article published Nov 1, 2025)
- Why
- Health Canada issued a notice of non-compliance for the ANDA, indicating the application for the generic drug Semaglutide requires further details or has not met compliance standards.
Key facts
- Company
- Dr Reddy's Laboratories
- Stock Movement
- Down 4% on Thursday
- Regulatory Body
- Health Canada
- Application Type
- Abbreviated New Drug Application (ANDA)
- Drug
- Semaglutide (weight loss drug, peptide, GLP-1RA)
- Issue
- Notice of Non-Compliance
Quotes
Preethi
A person discussing stock market news and pharmaceutical applications.
“No it depends on the molecules and their action. Firstly, there are small molecules and complex molecules for which you make generics. Small you would understand, complex, let me explain. Complex can be biologics, peptides, or inhalations or even some injectables. Semaglutide is a peptide, Glucagon Like Peptide receptor agonist (GLP-1RA) which acts similar to the natural peptide in the gut. One would expect a higher bar for approval as with the case of US FDA which left Cipla, Lupin, Sun Pharma in several review cycles before approval.”
thehindubusinessline.com
“Sure, lets start with ANDA submissions, which are the bread and butter for Indian Pharma. ANDA - Abbreviated New Drug Application as the name states is simply a shorter dossier for applying for a generic drug. The dossier is shorter because the applicant company is using the research findings of the original applicant or the innovator. Except for rare instances, the generic applicant must establish that the generic will react with the patient in the same manner as the innovator drug, which is establishing bioequivalence.”
thehindubusinessline.com
Arjun
A person seeking clarification on pharmaceutical industry terms.
“My understanding of pharma is a bit vague. Except for weight loss and ‘down 4 per cent’ I am hazy about other things; can you please elaborate?”
thehindubusinessline.com
“So if the higher bar is to be expected and several review cycles were the norm, the 4 per cent correction seems a bit overdone don’t you think?”
thehindubusinessline.com
