Download Brochure
X
Irbesartan API
CAS Number: 138402-11-6
Irbesartan API
Therapeutic Category
Anti-hypertensive
Cardiovascular
API Technology
Synthetic
Dose Form
Oral Solids
Dr Reddy's Development Status
Available
Available Regulatory Filing
USA, CEP
Mechanism of Action
Irbesartan and all ARB agents are primarily AT1-receptor antagonists—that is, the drug competes with angiotensin II for binding at the AT1-receptor subtype. Irbesartan's inhibition of angiotensin II binding to the AT1 receptor leads to several effects including vasodilation, a reduction in secretion of vasopressin (a hormone involved in water retention), and reduction in production and secretion of aldosterone (a hormone involved in hypertension regulation). The resultant effect is a net decrease in blood pressure.
Indication
AVAPRO is an angiotensin II receptor blocker (ARB) indicated for:
- Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
- Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria
Dr. Reddy's Expertise
Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Irbesartan API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.
Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Irbesartan API is the outcome of the extensive expertise in R&D, IP, and Regulatory.
A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.
Related Resources
EMA Nitrosamine Guidance – Deadline March 31, 2021
MAHs should ensure that they and the manufacturing authorization holder have access to all relevant information from the API manufacturers about the potential formation of nitrosamine impurities and the potential for cross-contamination.
The call for review consists of the following three steps:
- Step 1: MAHs to perform a risk evaluation to identify if APIs and/or FPs could be at risk of the presence of N-nitrosamine under the principles outlined in Q&A 7 of the Q&A for the implementation article 5(3):
- Step 2: If a risk is identified, MAHs to proceed with confirmatory testing to confirm or refute the presence of N-nitrosamines, accordance with the principles outlined in Q&As 8 and 9 of the Q&A for the implementation of Article 5(3). MAHs should report the outcomes as soon as possible.
- Step 3: If the presence of N-nitrosamine(s) is confirmed, MAHs should implement effective risk-mitigating measures through the submission of variations:
− to be undertaken before September 26, 2022, for human medicines containing chemically synthesized APIs;
− to be conducted before July 1 2023, for human medicines containing biological active substances.
MAHs are required to respond to the RAs on the outcome of step 1 and step 2 by utilizing agreed published templates provided on the EMA/ CMDh websites.
How we can help
Our regulatory and scientific experts at Dr. Reddy’s were amongst the forerunners in addressing the issue right from the beginning. We provide our customers with a full assessment for all our sartan APIs, which confirm the absence of NDMAs and analytical testing that already comply with the new acceptance limits. In addition to sartan APIs, we’ve performed a complete Step-1 nitrosamine assessment for around 270 chemically synthesized APIs.
Please contact our team of experts at [email protected] for any queries. You can also find further information on our sartan API approach in the whitepaper here
Read More
Disclaimer
No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.
Insights Delivered
Sign-up for our email service to get Market and Product insights and updates right to your digital doorstep
The categories of personal information collected in this form include name, company, and contact information etc. The personal information collected will be used for exploratory discussions on contract manufacturing, marketing and to perform research and analytics and others. For more information about the categories of personal information collected by Dr.Reddy's and the purposes for which Dr.Reddy's uses personal information, visit https://api.drreddys.com/privacy-policy.