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Losartan Potassium

Losartan Potassium-API

Losartan Potassium API

CAS Number: 124750-99-8

About Losartan Potassium API

Therapeutic Category
Cardiovascular

API Technology
Synthetic

Dose Form
Oral Solids

Dr Reddy's Development Status
Available

Available Regulatory Filing
USDMF

Mechanism of Action

Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)] is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g., vascular smooth muscle, adrenal gland). There is also an AT2 receptor found in many tissues but it is not known to be associated with cardiovascular homeostasis. Neither losartan nor its principal active metabolite exhibits any partial agonist activity at the AT1 receptor, and both have much greater affinity (about 1000-fold) for the AT1 receptor than for the AT2 receptor. In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT1 receptor. The active metabolite is 10 to 40 times more potent by weight than losartan and appears to be a reversible, non-competitive inhibitor of the AT1 receptor.

Neither losartan nor its active metabolite inhibits ACE (kininase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin), nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Indication

COZAAR is an angiotensin II receptor blocker (ARB) indicated for:

  • Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2)
  • Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.

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 Losartan Potassium 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 Losartan Potassium 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.

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EMA Nitrosamine Guidance – Deadline March 31, 2021

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): March 31, 2021, for human medicines containing chemically synthesized APIs; − to be conducted before July 1, 2021, for human medicines containing biological active substances.
  • 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.

EMA Nitrosamine Guidance – Deadline March 31, 2021

Source:https://www.ema.europa.eu/en/documents/referral/european-medicines-regulatory-network-approach-implementation-chmp-opinion-pursuant-article-53/2004-nitrosamine-impurities-human-medicines_en.pdf

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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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.

FAQs

Assess any muscle pain or back pain to rule out musculoskeletal pathology; that is, try to determine if pain is drug-induced rather than caused by anatomical or biomechanical problems.

Used to treat high blood pressure. It is also used for diabetic kidney disease, heart failure, and left ventricular enlargement.

Diabetic Nephropathy, Hypertension - 50 mg orally(100 mg max).Pediatric Dose for Hypertension - 0.7 mg/kg orally once a day (up to 50 mg total).

We offer Form-1

Meet with our product experts in one-on-one virtual sessions at https://api.drreddys.com/meet-api-experts or Write to us at api@drreddys.com.

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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.

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.