Understanding Nateglinide
Nateglinide is an oral medication used in conjunction with diet and exercise to manage type 2 diabetes [1.3.1]. It belongs to a class of drugs known as meglitinides [1.3.6]. The primary function of nateglinide is to stimulate the pancreas to release more insulin into the bloodstream, particularly in response to a meal [1.3.2, 1.6.2]. This rapid, short-acting mechanism helps control postprandial (after-meal) blood sugar spikes [1.7.1]. It's important to note that nateglinide is not for treating type 1 diabetes, as it relies on the pancreas's ability to produce insulin [1.3.2]. The medication is available under the brand name Starlix and also as a generic [1.7.1].
What is the Current Price of Nateglinide API?
The price of nateglinide Active Pharmaceutical Ingredient (API) is not fixed and demonstrates significant volatility based on a variety of factors [1.4.8]. Listings from suppliers, primarily in India, show a wide price range, from as low as 100 INR/kg to as high as 25,000 INR/kg (approximately $1.20 to $300 USD/kg) [1.2.1]. For smaller, research-grade quantities, prices can be much higher, such as $180 USD for 50mg [1.2.7]. This variation underscores that the final price is subject to negotiation, order volume, supplier reputation, and the required quality grade [1.2.8].
Key Factors Influencing Nateglinide API Price
The cost of nateglinide API is determined by a complex interplay of market and manufacturing dynamics:
- Raw Material Costs: The availability and price of chemical precursors needed for synthesis are primary cost drivers [1.4.2].
- Manufacturing and Technology: The complexity of the synthesis process and investment in modern technologies like continuous manufacturing can affect production costs [1.4.3]. High purity requirements (e.g., USP/BP grade) also add to the expense [1.4.4].
- Regulatory Compliance: Adherence to strict regulatory standards, such as Good Manufacturing Practices (GMP) set by bodies like the FDA and EMA, involves significant investment in quality control and documentation, thereby increasing costs [1.4.2, 1.4.3].
- Supply Chain and Logistics: The global pharmaceutical supply chain is vulnerable to disruptions, including transportation costs, geopolitical tensions, and tariffs, all of which can cause price volatility [1.4.8]. Many API manufacturers are located in India and China, making logistics a critical factor [1.5.2, 1.5.7].
- Market Competition and Demand: The presence of multiple manufacturers, including prominent Indian companies like Cipla, Unichem Laboratories, and Zydus Lifesciences, fosters competition that can influence prices [1.5.4]. The demand for generic nateglinide, which is significantly cheaper than its brand-name counterpart Starlix, also plays a crucial role [1.7.4].
- Patent Status: When a drug's patent expires, it opens the market to generic manufacturers, which typically leads to a significant drop in price due to increased competition [1.4.7].
Sourcing Nateglinide API
When sourcing nateglinide API, buyers should prioritize verifying supplier credentials. This includes requesting a Certificate of Analysis (CoA) to confirm the product's purity and quality standards. It is also essential to ensure the manufacturer complies with GMP standards to guarantee the safety and efficacy of the final drug product [1.4.2]. Many nateglinide API suppliers are based in India, with companies like Ind-Swift Labs, USV, and Cipla being notable producers [1.5.2]. Platforms like Pharmaoffer and aPicule list numerous verified suppliers from various countries [1.5.2, 1.5.4].
Comparison of Oral Antidiabetic APIs
Nateglinide occupies a specific niche among oral treatments for type 2 diabetes. Its profile differs from other common agents.
| Feature | Nateglinide (Meglitinide) | Metformin (Biguanide) | Glipizide (Sulfonylurea) |
|---|---|---|---|
| Primary Mechanism | Stimulates rapid, short-term insulin release from the pancreas [1.6.2]. | Decreases glucose production by the liver and improves insulin sensitivity. | Stimulates insulin release from the pancreas over a longer duration. |
| Use Case | Best for controlling after-meal blood sugar spikes [1.7.1]. | Often a first-line therapy for overall glycemic control [1.3.2]. | Used for general blood sugar management. |
| Dosing | Taken 1-30 minutes before each meal [1.3.5]. | Typically taken once or twice daily with meals. | Usually taken once or twice daily. |
| Hypoglycemia Risk | Yes, especially if a meal is skipped [1.6.4]. | Very low risk when used alone. | Higher risk compared to metformin. |
| Generic Availability | Widely available [1.7.1]. | Widely available. | Widely available. |
Conclusion
Determining 'what is the price of nateglinide API?' reveals a fluctuating and complex market rather than a single fixed number. The cost is shaped by a confluence of factors, from raw material costs and manufacturing standards to regulatory hurdles and global supply chain stability [1.4.8]. While the entrance of generic manufacturers has made the drug more accessible, purchasers must conduct thorough due diligence, verifying supplier quality and navigating a market with significant price variations. Understanding these dynamics is crucial for any entity involved in the manufacturing of this important diabetes medication.
For more detailed information on drug approvals and manufacturer information, one authoritative source is the FDA's database [1.6.4].
