Finerenone API

Finerenone API
Details:
Finerenone API (CAS 1050477-31-0) is a new-generation nonsteroidal cardiorenal protective drug substance with highly selective mineralocorticoid receptor antagonism, providing core pharmaceutical raw material support for diabetic chronic kidney disease.
  • CAS Number 1050477-31-0
  • Formula C21H22N4O3
  • Storage Store at 2–8°C
  • Documentation US/EU/CADIFA
Send Inquiry
Download
Description
Technical Parameters

HK Neopharm Limited is one of the most reliable manufacturers and suppliers of finerenone api in China, featured by quality products and good price. Please rest assured to buy finerenone api in stock here and get quotation from our factory. Customized orders are welcome.

 

Finerenone API (CAS 1050477-31-0) is a new-generation nonsteroidal cardiorenal protective drug substance with highly selective mineralocorticoid receptor antagonism, providing core pharmaceutical raw material support for diabetic chronic kidney disease. As reliable China Finerenone API manufacturers, we supply high-quality Finerenone Powder and Finerenone Pharmaceutical API, which have no obvious cross-reactivity with other steroid receptors and excellent clinical safety. Clients worldwide can securely buy Finerenone API with confidence.

 

Technical Specifications

 

 

Product Name

Finerenone API

Synonyms

Finerenone Powder, Finerenone Raw Material

Characteristics

A white or off-white crystalline powder

CAS Number

1050477-31-0

Assay

≥99.0% (HPLC, Subject to the COA)

Formula

C21H22N4O3

Package

Technical Package

Storage

Storage: Store at 2–8°C, tightly sealed, dry and protected from light.

Long-term stability:

-20°C: Stable for 3 years as powder.

4°C (2–8°C): Stable for 2 years.

Room temperature (<30°C): For short-term use only; not recommended for long-term storage.

Structure

product-236-236

Produced under advanced synthetic processes and full-process GMP quality control, this High Purity Finerenone API (purity ≥99.0%, HPLC) features low impurities and excellent batch consistency. As a leading China Finerenone Raw Material factory, it fully meets the needs of innovative drug R&D, clinical trials and large-scale production, providing reliable raw material support for chronic disease therapeutics. We have adequate Finerenone Powder in stock and offer Finerenone API Free Sample for evaluation.

 

 
 
Product Features

Finerenone API

Finerenone API (CAS 1050477-31-0) is a highly selective mineralocorticoid receptor antagonist with no significant cross-reaction with other steroid receptors including glucocorticoid and androgen receptors. Its precise targeting effectively reduces off-target effects, resulting in prominent safety advantages in clinical applications.

Finerenone API

Supported by mature synthetic technology and full-cycle quality management, the product is manufactured in strict compliance with pharmacopoeial standards, with purity ≥99.0% (HPLC), controllable impurities, and excellent batch stability and consistency. Complete COA is provided for each batch to meet regulatory production requirements.

As a core drug substance in the cardiorenal field, Finerenone Raw Material is fully adaptable to innovative drug R&D, clinical trials, and large-scale commercial production. It provides high-quality, traceable core raw material support for the development of therapeutics for type 2 diabetes-related chronic kidney disease.

 

Full-Cycle Quality Control & Consistent Quality

 

High Purity Finerenone API implements standardized SOPs throughout the entire process from raw material feeding, synthetic reaction to refining and purification, with real-time monitoring at key nodes to avoid quality risks from the source and ensure batch consistency.

 

 

 

Each batch undergoes comprehensive tests including HPLC, moisture, heavy metals, and more, with purity ≥99.0% and impurity levels strictly conforming to pharmacopoeial standards. Complete COA is issued to ensure every batch meets compliant production requirements.

 

 

Supported by a mature production system and continuous process optimization, the product delivers excellent long-term stability with controllable quality fluctuations between batches. It enables stable supply for large-scale production and satisfies customers' long-term, bulk raw material demands. We maintain adequate Finerenone API in stock for urgent needs.

 

 

A complete quality traceability system is established, covering raw material sourcing, production records, and finished product release. Strictly compliant with GMP standards, it provides customers with traceable and highly reliable quality assurance for Finerenone Raw Material made in China. We also offer Finerenone API Free Sample for evaluation upon request.

 

Application Scenarios

 

 

As a new-generation highly selective mineralocorticoid receptor antagonist, Finerenone Pharmaceutical API possesses extensive and core applications in pharmaceutical R&D and manufacturing thanks to its excellent pharmacological activity and stable quality. It covers the entire industrial chain from innovative R&D to commercial production, with specific scenarios as follows:

 

Finerenone Raw Material serves as a core raw material for innovative drug R&D in the cardiorenal field, applicable to preclinical studies and clinical trials of new drugs for type 2 diabetes with chronic kidney disease, supplying high-quality experimental raw materials for research institutions.

 

The product adapts to the large-scale production needs of oral tablets and other formulations, stably supplying pharmaceutical enterprises for commercial manufacturing and supporting the market launch of High Purity Finerenone API-based medicines, ensuring raw material supply for long-term treatment of chronic kidney disease patients.

Finerenone Application Scenarios

 

As a benchmark raw material for nonsteroidal mineralocorticoid receptor antagonists, Finerenone Raw Material can be used for generic drug formulation development, process optimization, and consistency evaluation, helping pharmaceutical companies accelerate generic drug registration and expand the cardiorenal disease drug market.

 

It can be used as a high-end pharmaceutical intermediate for structural modification of derivative compounds and new drug screening, supporting pharmaceutical companies in expanding their cardiorenal protection pipelines and meeting diversified demands for customized R&D and small-batch trial production. We support Customized Finerenone API for special projects.

Packaging and Transportation
 
 

Packaging and transportation of Finerenone Powder strictly follow GMP standards for active pharmaceutical ingredients, balancing product protection, storage safety, and logistics efficiency. The entire process from packaging design to transportation control is standardized to maintain product purity and stability.

 

Customized Packaging Solutions

We provide multi-specification customized packaging, including aluminum foil bags and sealed steel drums. Small-batch trial packages and large-scale commercial packages are available according to customer needs. The inner layer uses moisture-proof and oxygen-barrier materials to effectively protect the product from humidity and air exposure.

 
 

Professional Protective Packaging Design

The outer packaging is equipped with anti-pressure buffers and anti-leakage structures, suitable for long-distance transportation and multiple transfers. Clear product information, batch numbers, and storage instructions are labeled for easy logistics identification, reducing risks of mishandling.

 
 

Precise Cold-Chain Transportation Control

In view of the product's low-temperature storage requirements, professional cold-chain transportation is provided with a room temperature, protected from light and moisture. Temperature recorders monitor real-time changes to ensure product quality remains intact and meets strict requirements for raw material activity.

 
 

Full-Link Logistics Support System

A dedicated logistics coordination mechanism is established to plan optimal routes and shorten delivery time. Real-time logistics tracking is available, and complete quality inspection documents and shipping certificates are provided for each batch, ensuring full traceability from warehouse to customer delivery.

 

 

 
 
Our Advantages

Process & Quality Advantage

We possess mature independent synthetic processes and large-scale production capacity for Finerenone Powder, with full compliance to GMP standards. The product features high purity, controllable impurities, and excellent batch stability, reliably fulfilling customers' large orders and long-term supply needs.

Full-Chain Quality Control Advantage

We have established a full-cycle quality system covering raw material traceability, production control, and finished product release. Each batch undergoes strict multi-dimensional testing with complete COA issued, strictly conforming to pharmacopoeial standards, providing customers with traceable and reliable quality assurance.

Customized Service Advantage

We provide customized specifications, packaging, and R&D support according to customer needs, covering all stages from laboratory trials to industrial production. Supported by professional cold-chain logistics and responsive technical services, we help customers advance projects efficiently. As professional China Finerenone API suppliers, we prioritize stable and flexible support.

 

FAQ

 

Q1: What are the storage conditions and shelf life of this Finerenone Pharmaceutical API?

A1: Should be placed in a sealed container and stored at 2–8°C in a dry and dark place. For long-term storage, it can be kept at -20°C. Under the specified storage conditions, the shelf life is 2 years, and it can be stably stored for 3 years at -20°C. It is recommended to use promptly after first opening to avoid repeated temperature and humidity fluctuations.

Q2: How to ensure batch-to-batch consistency of High Purity Finerenone API?

A2: We have established a full life cycle quality control system, including supplier audit, key intermediate control, comprehensive testing (HPLC, GC, IC, etc.), and stability studies, ensuring minimal fluctuation of key quality parameters such as purity and impurity profile.

Q3: Can your company provide compliance documents for Finerenone Raw Material?

A3: Yes. We provide COA for each batch, as well as complete documents including DMF, GMP certificates, and pharmacopoeia compliance statements, supporting drug registration, clinical application, and commercial production worldwide.

Q4: How do you ensure continuous cooperation amid market or policy changes?

A4: We have a complete risk response mechanism with advanced supply chain and capacity planning, actively adapting to policy requirements to minimize external impacts on long-term partnerships.

 

The company strictly abides by pharmaceutical production regulations, prioritizes product quality and medication safety, and specializes in producing high-purity, stable Finerenone API (CAS 1050477-31-0) with fully controllable and traceable production. From process R&D to large-scale stable supply, we provide reliable raw material support for cardiorenal disease drug development. We sincerely invite global customers to cooperate, promote innovative drug development with high-quality raw materials, and build a long-term, win-win industrial ecosystem.

 

Hot Tags: finerenone API, China finerenone API manufacturers, suppliers, factory

Send Inquiry