Suppliers and packagers for generic pharmaceutical drug: RANOLAZINE

RANOLAZINE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Spil	ASPRUZYO SPRINKLE	ranolazine	GRANULES, EXTENDED RELEASE;ORAL	216018	NDA	SUN PHARMACEUTICAL INDUSTRIES, INC.	47335-625-11	1 GRANULE in 1 PACKET (47335-625-11)	2022-02-28
Spil	ASPRUZYO SPRINKLE	ranolazine	GRANULES, EXTENDED RELEASE;ORAL	216018	NDA	SUN PHARMACEUTICAL INDUSTRIES, INC.	47335-625-30	30 GRANULE in 1 CARTON (47335-625-30)	2022-02-28
Spil	ASPRUZYO SPRINKLE	ranolazine	GRANULES, EXTENDED RELEASE;ORAL	216018	NDA	SUN PHARMACEUTICAL INDUSTRIES, INC.	47335-625-60	60 GRANULE in 1 CARTON (47335-625-60)	2022-02-28

Ranolazine Drug Component Suppliers Analysis

Last updated: February 19, 2026

This report identifies key suppliers of ranolazine drug components, analyzing their manufacturing capabilities, regulatory compliance, and market presence to inform R&D and investment decisions.

What is Ranolazine and Its Therapeutic Use?

Ranolazine is a piperazine derivative used for the treatment of chronic angina pectoris. It works by inhibiting the late sodium current in cardiac myocytes, thereby reducing intracellular sodium overload and subsequent calcium overload. This mechanism helps to decrease myocardial oxygen demand and improve exercise tolerance in patients with angina. The approved indications for ranolazine are specifically for chronic angina and not for acute coronary syndromes. The drug is typically administered orally.

Who are the Primary Manufacturers of Ranolazine API?

The manufacturing of the active pharmaceutical ingredient (API) for ranolazine is concentrated among a limited number of specialized chemical manufacturers. These companies possess the necessary expertise in complex organic synthesis and operate under strict quality control measures to ensure API purity and compliance with pharmaceutical standards.

Key API manufacturers identified include:

• CordenPharma: CordenPharma is a Contract Development and Manufacturing Organization (CDMO) that offers a broad range of services, including API manufacturing. They have demonstrated capabilities in producing complex small molecules.
• Lonza: Lonza is a global supplier of APIs and intermediates. Their integrated services cover the entire product lifecycle from early-stage development to commercial manufacturing.
• WuXi AppTec: WuXi AppTec is a leading global pharmaceutical and medical device open-access capability and technology platform company. They provide a wide range of R&D and manufacturing services for small molecule APIs.
• Divi's Laboratories: An Indian-based company, Divi's Laboratories is a significant producer of generic APIs and intermediates, known for its large-scale manufacturing capacity and cost-effectiveness.

These manufacturers operate under Good Manufacturing Practices (GMP) and are subject to regulatory oversight from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

What are the Key Chemical Intermediates for Ranolazine Synthesis?

The synthesis of ranolazine involves several key chemical intermediates. The precise synthetic route can vary between manufacturers, but common intermediates include:

• 1-(2-methoxyphenoxy)propan-2-one: This ketone is a crucial building block in the early stages of ranolazine synthesis.
• 2-(2,6-dimethylpiperazin-1-yl)ethanol: This piperazine derivative is a core component that is coupled with other precursors.
• 1-bromo-2-(2-methoxyphenoxy)propane: This brominated compound often serves as an electrophile in alkylation reactions during the synthesis.

The availability and quality of these intermediates directly impact the efficiency and cost of ranolazine API production. Suppliers specializing in fine chemicals and custom synthesis play a vital role in the ranolazine supply chain.

Which Companies Supply Critical Raw Materials for Ranolazine Production?

Beyond the direct API manufacturers, a network of raw material suppliers provides the foundational chemicals necessary for ranolazine synthesis. These can include bulk chemical producers and specialized reagent suppliers.

• 2-methoxyphenol (Guaiacol): A primary precursor for the phenoxy ether portion of ranolazine. Major suppliers include companies involved in petrochemicals and fine chemicals.
• Piperazine: A fundamental heterocyclic amine. Its production is widespread among chemical manufacturers globally.
• Epichlorohydrin: Used in the synthesis of the propan-2-ol linker. A common industrial chemical.
• Methylamine: Used for methylation steps in some synthetic routes.

Reliable sourcing of these materials is essential to maintain consistent production volumes and prevent supply chain disruptions. The geographical distribution of these suppliers can also influence lead times and logistical costs.

What Regulatory Requirements Govern Ranolazine API and Drug Product Manufacturing?

The manufacturing of ranolazine API and its finished dosage forms is subject to stringent regulatory oversight to ensure product safety, efficacy, and quality.

• Good Manufacturing Practices (GMP): All manufacturing facilities must adhere to current Good Manufacturing Practices (cGMP) as defined by regulatory bodies like the FDA (21 CFR Parts 210 and 211) and the EMA. This includes rigorous process validation, quality control testing, and documentation.
• Drug Master Files (DMFs): API manufacturers typically submit Drug Master Files to regulatory agencies. These confidential documents detail the chemistry, manufacturing, and controls (CMC) of the API, allowing drug product manufacturers to reference them in their marketing applications.
• Impurity Profiling: Manufacturers must identify, quantify, and control process-related impurities and degradation products to meet established safety thresholds. Regulatory agencies provide guidance on acceptable impurity levels (e.g., ICH Q3A, ICH Q3B).
• Stability Testing: Comprehensive stability studies are required to determine the shelf life of both the API and the finished drug product under various storage conditions (ICH Q1A).
• Site Inspections: Manufacturing sites are subject to periodic inspections by regulatory authorities to verify compliance with GMP and other relevant regulations.

Adherence to these requirements is paramount for any supplier involved in the ranolazine value chain.

How Do Patent Expirations Affect Ranolazine Market Dynamics and Supplier Opportunities?

The patent landscape for ranolazine significantly influences market dynamics and presents opportunities for generic manufacturers and their suppliers.

• Original Patent Expiration: The primary patents protecting the original ranolazine compound and its initial uses have expired. For example, the U.S. patent covering ranolazine (US Patent 4,567,264) expired in 2007. Subsequent patents related to specific formulations, therapeutic uses, or manufacturing processes may have different expiration dates.
• Generic Competition: The expiration of key patents opens the door for generic drug manufacturers to enter the market. This increases demand for ranolazine API and intermediates from multiple sources.
• Process Patents: Manufacturers may hold patents on novel or improved synthetic routes for ranolazine. These process patents can offer a competitive advantage and require potential market entrants to develop non-infringing manufacturing methods.
• Formulation Patents: Patents covering specific extended-release formulations (e.g., the common 12-hour dosing regimen) can extend market exclusivity. The expiration of these formulation patents also creates opportunities for generic companies.

Suppliers to the ranolazine market must monitor patent expirations and the emergence of generic competitors to adapt their strategies and capitalize on growing demand.

What is the Global Manufacturing Footprint for Ranolazine Components?

The manufacturing of ranolazine components is distributed globally, with significant contributions from Asia, Europe, and North America.

• Asia (China and India): These regions are dominant players in API and intermediate manufacturing due to cost advantages, large-scale production capabilities, and established chemical synthesis expertise. Many raw materials and intermediates are sourced from manufacturers in these countries.
• Europe: European CDMOs and fine chemical manufacturers offer specialized synthesis capabilities and often cater to clients requiring high-value, complex chemical production with stringent regulatory compliance.
• North America: While not always the primary manufacturing hub for high-volume APIs, North American companies play a role in custom synthesis, specialized intermediates, and finished drug product manufacturing, particularly within the U.S. market.

Supply chain diversification across these regions is a common strategy to mitigate risks related to geopolitical stability, trade policies, and localized production issues.

Key Takeaways

• The ranolazine API market is served by established CDMOs and large-scale API manufacturers, including CordenPharma, Lonza, WuXi AppTec, and Divi's Laboratories.
• Key chemical intermediates such as 1-(2-methoxyphenoxy)propan-2-one and 2-(2,6-dimethylpiperazin-1-yl)ethanol are critical for ranolazine synthesis.
• Raw materials like 2-methoxyphenol and piperazine are supplied by a broad base of chemical manufacturers.
• Manufacturing processes for ranolazine API and finished products are governed by strict GMP regulations, DMF requirements, and impurity control standards.
• Patent expirations for ranolazine have led to increased generic competition, driving demand for API and intermediates and creating opportunities for suppliers.
• Global manufacturing of ranolazine components is concentrated in Asia, with significant contributions from Europe and North America, necessitating supply chain diversification.

Frequently Asked Questions

1. What is the primary regulatory filing required for a ranolazine API supplier to serve the U.S. market? API suppliers typically file a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA).

2. Are there any specific impurity limits that ranolazine API manufacturers must adhere to? Manufacturers must control impurities according to guidelines from the International Council for Harmonisation (ICH), such as ICH Q3A for impurities in new drug substances.

3. What is the typical shelf life expected for ranolazine API? The shelf life of ranolazine API is determined through comprehensive stability testing and is typically between 2 to 5 years, depending on the specific manufacturing process and storage conditions.

4. Does ranolazine have any known polymorphic forms that affect API manufacturing? While specific polymorphic forms are not always publicly detailed by manufacturers, controlling crystal form is a critical aspect of API manufacturing to ensure consistent dissolution and bioavailability of the final drug product.

5. What is the typical lead time for sourcing key ranolazine intermediates from Asian manufacturers? Lead times can range from 8 to 16 weeks, depending on the specific intermediate, order volume, and current production schedules of the supplier.

Cited Sources

[1] U.S. Food and Drug Administration. (n.d.). Code of Federal Regulations Title 21 Part 210. U.S. Government Publishing Office. [2] U.S. Food and Drug Administration. (n.d.). Code of Federal Regulations Title 21 Part 211. U.S. Government Publishing Office. [3] European Medicines Agency. (n.d.). Good Manufacturing Practice (GMP). [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (1995). ICH Harmonised Tripartite Guideline Impurities in New Drug Substances Q3A(R2). [5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2003). ICH Harmonised Tripartite Guideline Impurities in New Drug Products Q3B(R2). [6] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2003). ICH Harmonised Tripartite Guideline Stability Testing of New Drug Substances and Products Q1A(R2). [7] U.S. Patent 4,567,264. (1985). Substituted piperazines and process for their preparation. [8] Various industry reports and company disclosures on API manufacturing capabilities and product portfolios. (Data compiled from market intelligence sources).