Sacubitril / Valsartan API
CAS Number: 936623-90-4
About Sacubitril / Valsartan API
Therapeutic Category
Cardiovascular
API Technology
Synthetic
Dose Form
Oral Solids
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF
Mechanism of Action
ENTRESTO contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. ENTRESTO inhibits neprilysin (neutral endopeptidase; NEP) via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 (AT1) receptor via valsartan. The cardiovascular and renal effects of ENTRESTO in heart failure patients are attributed to the increased levels of peptides that are degraded by neprilysin, such as natriuretic peptides, by LBQ657, and the simultaneous inhibition of the effects of angiotensin II by valsartan. Valsartan inhibits the effects of angiotensin II by selectively blocking the AT1 receptor, and also inhibits angiotensin II-dependent aldosterone release
Indication
ENTRESTO is a combination of sacubitril, a neprilysin inhibitor, and valsartan, an angiotensin II receptor blocker, indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
ENTRESTO is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other ARB.
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 Sacubitril / Valsartan 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 Sacubitril / Valsartan 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
Sacubitril/Valsartan (LCZ696) – Bringing yet another advantage through innovative API offerings
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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 api@drreddys.com for any queries. You can also find further information on our sartan API approach in the whitepaper here
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Dr. Reddy’s is featured in an article of Global Pharma Insights on “Nitrosamine contamination: pharma’s re-evaluation of its supply chain”
Dr. Reddy’s was one of the very first API manufacturers to instigate a complete review to ensure that nitrosamine impurities are avoided by design and analytical methods are in place which meet the future stringent limits which have been set by regulatory agencies.
On winning the API Supplier of the Year award at the Generics Bulletin’s Annual Global Generics & Biosimilars Awards 2019, Dr. Reddy’s was also commended on the proactive and methodical approach followed to address the nitrosamine impurities situation with Sartan APIs (such as Valsartan).
Read the complete article here:
You can also read our whitepaper on “Meeting the New Regulatory Requirements in Sartan API Production” by clicking here:
https://api.drreddys.com/white-paper/meeting-new-regulatory-requirements-sartan-api-production-0
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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.
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