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Looking for 1350653-20-1 / Vericiguat API manufacturers, exporters & distributors?

Vericiguat manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Vericiguat API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Vericiguat manufacturer or Vericiguat supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vericiguat manufacturer or Vericiguat supplier.

PharmaCompass also assists you with knowing the Vericiguat API Price utilized in the formulation of products. Vericiguat API Price is not always fixed or binding as the Vericiguat Price is obtained through a variety of data sources. The Vericiguat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Vericiguat

Synonyms

1350653-20-1, Verquvo, Methyl (4,6-diamino-2-(5-fluoro-1-(2-fluorobenzyl)-1h-pyrazolo[3,4-b]pyridin-3-yl)pyrimidin-5-yl)carbamate, Mk-1242, Vericiguat [inn], Bay-1021189

Cas Number

1350653-20-1

Unique Ingredient Identifier (UNII)

LV66ADM269

About Vericiguat

Vericiguat is a direct stimulator of soluble guanylate cyclase (sGC) used in the management of systolic heart failure to reduce mortality and hospitalizations. A key component of the NO-sGC-cGMP signaling pathway that helps to regulate the cardiovascular system, sGC enzymes are intracellular enzymes found in vascular smooth muscle cells (amongst other cell types) that catalyze the synthesis of cyclic guanosine monophosphate (cGMP) in response to activation by nitric oxide (NO). Cyclic GMP acts as a second messenger, activating a number of downstream signaling cascades that elicit a broad variety of effects, and these diverse cellular effects have implicated deficiencies in its production (primarily due to insufficient NO bioavailability) in the pathogenesis of various cardiovascular diseases. As a direct stimulator of sGC, vericiguat mitigates the need for a functional NO-sGC-cGMP axis and thereby helps to prevent the myocardial and vascular dysfunction associated with decreased sGC activity in heart failure. Vericiguat was approved by the FDA in January 2021 - developed by Merck under the brand name Verquvo - for use in certain patients with systolic heart failure. Although not the first sGC stimulator to be granted FDA approval ([riociguat] was approved in 2013 for use in pulmonary hypertension), vericiguat is unique amongst its peers in that modifications to its structure have dramatically decreased its susceptibility to oxidative metabolism, resulting in a relatively long half-life and allowing for once-daily dosing.

Vericiguat Manufacturers

A Vericiguat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vericiguat, including repackagers and relabelers. The FDA regulates Vericiguat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vericiguat API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Vericiguat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Vericiguat Suppliers

A Vericiguat supplier is an individual or a company that provides Vericiguat active pharmaceutical ingredient (API) or Vericiguat finished formulations upon request. The Vericiguat suppliers may include Vericiguat API manufacturers, exporters, distributors and traders.

click here to find a list of Vericiguat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Vericiguat USDMF

A Vericiguat DMF (Drug Master File) is a document detailing the whole manufacturing process of Vericiguat active pharmaceutical ingredient (API) in detail. Different forms of Vericiguat DMFs exist exist since differing nations have different regulations, such as Vericiguat USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Vericiguat DMF submitted to regulatory agencies in the US is known as a USDMF. Vericiguat USDMF includes data on Vericiguat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vericiguat USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Vericiguat suppliers with USDMF on PharmaCompass.

Vericiguat KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Vericiguat Drug Master File in Korea (Vericiguat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vericiguat. The MFDS reviews the Vericiguat KDMF as part of the drug registration process and uses the information provided in the Vericiguat KDMF to evaluate the safety and efficacy of the drug.

After submitting a Vericiguat KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Vericiguat API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Vericiguat suppliers with KDMF on PharmaCompass.

Vericiguat GMP

Vericiguat Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Vericiguat GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Vericiguat GMP manufacturer or Vericiguat GMP API supplier for your needs.

Vericiguat CoA

A Vericiguat CoA (Certificate of Analysis) is a formal document that attests to Vericiguat's compliance with Vericiguat specifications and serves as a tool for batch-level quality control.

Vericiguat CoA mostly includes findings from lab analyses of a specific batch. For each Vericiguat CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Vericiguat may be tested according to a variety of international standards, such as European Pharmacopoeia (Vericiguat EP), Vericiguat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vericiguat USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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