Share This Page
Suppliers and packagers for generic pharmaceutical drug: RABEPRAZOLE SODIUM
✉ Email this page to a colleague
RABEPRAZOLE SODIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Waylis Therap | ACIPHEX | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020973 | NDA | Waylis Therapeutics LLC | 80725-243-30 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80725-243-30) | 2022-05-15 |
| Alkem Labs Ltd | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 208644 | ANDA | A-S Medication Solutions | 50090-4751-0 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4751-0) | 2018-04-27 |
| Alkem Labs Ltd | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 208644 | ANDA | A-S Medication Solutions | 50090-4751-1 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4751-1) | 2018-04-27 |
| Alkem Labs Ltd | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 208644 | ANDA | Quality Care Products, LLC | 55700-767-30 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (55700-767-30) | 2019-06-21 |
| Alkem Labs Ltd | RABEPRAZOLE SODIUM | rabeprazole sodium | TABLET, DELAYED RELEASE;ORAL | 208644 | ANDA | St. Mary's Medical Park Pharmacy | 60760-560-07 | 7 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-560-07) | 2019-09-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Rabeprazole Sodium
Introduction
Rabeprazole sodium, a proton pump inhibitor (PPI), is widely prescribed for conditions such as gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and gastric ulcers. Its efficacy in reducing gastric acid secretion has cemented its role in managing acid-related disorders. As demand for rabeprazole sodium grows globally, the pharmaceutical supply chain has expanded to encompass numerous suppliers spanning different regions. This report provides a comprehensive overview of key suppliers involved in the production and distribution of rabeprazole sodium, highlighting their manufacturing capabilities, regional presence, regulatory compliance, and market influence.
Global Market Overview
The global market for rabeprazole sodium is highly competitive, characterized by a mix of multinational pharmaceutical companies, third-party contract manufacturing organizations (CMOs), and generic drug producers. Major players supply both branded and generic formulations, with regions such as India, China, Europe, and the United States acting as pivotal hubs. The leadership landscape is shaped by innovation, regulatory approval, production capacity, and geopolitical factors influencing supply chains.
Major Suppliers of Rabeprazole Sodium
1. Dr. Reddy’s Laboratories (India)
Overview: Dr. Reddy’s is a prominent Indian pharmaceutical company with extensive expertise in active pharmaceutical ingredients (APIs). It manufactures rabeprazole sodium as part of its gastrointestinal product portfolio.
Capabilities: The company operates manufacturing facilities compliant with Good Manufacturing Practices (GMP) and has received approvals from regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Their capacity spans production of both bulk API and finished formulations.
Market Position: Dr. Reddy’s exports rabeprazole sodium to North America, Europe, and other markets. Its reputation for quality and cost-effective manufacturing makes it a significant player in the supply chain.
2. Jiangsu Hengrui Medicine Co., Ltd. (China)
Overview: A leading Chinese pharmaceutical exporter, Jiangsu Hengrui specializes in active pharmaceutical ingredients, including rabeprazole sodium, and is known for large-scale manufacturing.
Capabilities: Hengrui maintains GMP-certified facilities and supplies APIs to global manufacturers. Despite limited direct consumer branding, it serves as a crucial OEM partner.
Market Position: The company's extensive production capacity allows it to meet the rising demand driven by emerging markets, especially in Asia and Africa.
3. Alkem Laboratories (India)
Overview: Alkem Laboratories is a top Indian pharmaceutical company offering a broad range of APIs and formulations, including rabeprazole sodium.
Capabilities: Alkem’s API manufacturing facilities are GMP-compliant, and the company has secured regulatory approvals in the US, Europe, and other regions. Its focus on high-quality API supply supports its sizable domestic and export markets.
Market Position: As one of India's leading API producers, Alkem supplies rabeprazole sodium to both its formulation units and external clients.
4. Zhejiang Menovo Pharmaceutical Co., Ltd. (China)
Overview: Specializing in gastrointestinal APIs, Zhejiang Menovo supplies rabeprazole sodium globally.
Capabilities: The company maintains GMP certifications and emphasizes quality assurance in API manufacture. It caters primarily to the generic drug industry.
Market Position: Key supplier for generic pharmaceutical companies in India, Southeast Asia, and beyond.
5. Mylan (now part of Viatris) (Global)
Overview: A global pharmaceutical powerhouse, Mylan (Viatris) produces a range of APIs, including rabeprazole sodium, through strategic manufacturing arrangements and acquisitions.
Capabilities: Mylan’s API facilities worldwide, including in India and Europe, adhere to international regulatory standards, ensuring reliable supply.
Market Position: Mylan’s extensive distribution network provides broad access to rabeprazole sodium markets, particularly in North America and Europe.
6. Sun Pharmaceutical Industries Ltd. (India)
Overview: Sun Pharma is among the world's largest pharma companies and offers rabeprazole sodium across markets through its API manufacturing units.
Capabilities: The company’s GMP-certified plants produce high-quality APIs for domestic and international markets, including the US and Europe.
Market Position: Sun Pharma’s reputation for affordable and compliant APIs positions it as a key global supplier.
7. Aurobindo Pharma Limited (India)
Overview: Aurobindo offers a comprehensive portfolio of APIs, including rabeprazole sodium, with manufacturing plants compliant with global standards.
Capabilities: Its facilities in India and vis-à-vis international GMP standards support its role as a dependable supplier.
Market Position: Aurobindo’s competitive pricing and regulatory approvals enhance its market share among generic pharmaceutical companies.
8. Hubei Huida Pharmaceutical Co., Ltd. (China)
Overview: Specializes in APIs for the gastrointestinal segment, including rabeprazole sodium, catering mainly to Asian markets.
Capabilities: Known for high-volume API production, compliant with GMP standards.
Market Position: A significant supplier within China and neighboring regions.
9. Teva Pharmaceutical Industries Ltd. (Global)
Overview: Teva, one of the world's leading generic drug manufacturers, supplies rabeprazole sodium either as APIs or finished formulations through its vertical integration.
Capabilities: Maintains GMP-certified manufacturing units in Europe and the Middle East.
Market Position: Known for its vast distribution network, Teva plays a pivotal role in ensuring supply stability.
10. GlaxoSmithKline (GSK) (Global)
Overview: Though GSK has divested some of its gastrointestinal portfolios, some formulations and APIs remain under its manufacturing umbrella.
Capabilities: Its manufacturing facilities in Europe and Asia maintain high regulatory compliance.
Market Position: GSK continues to influence the supply landscape through existing manufacturing capacity and licensing agreements.
Supply Chain Dynamics and Regulatory Considerations
The supply chain for rabeprazole sodium relies heavily on regions with robust manufacturing standards, notably India and China. Regulatory compliance—particularly with the US FDA, EMA, and other agencies—is critical to enabling market access and export capabilities. The dynamic geopolitical landscape influences supplier selection, with ongoing concerns over trade tariffs, export restrictions, and quality assurance practices.
Manufacturers often participate in cGMP audits, and many have achieved regulatory approvals that affirm their manufacturing standards. These certifications impact buyer confidence and procurement strategies.
Emerging Trends in Supplier Markets
-
Increasing Focus on Compliance: Regulatory authorities intensify surveillance, prompting suppliers to upgrade manufacturing standards.
-
Strategic Diversification: Pharmaceutical companies diversify suppliers geographically to mitigate risks associated with regional disruptions.
-
Biologic and Alternative Therapies Impact: The rise of biologics may influence the demand for small-molecule PPIs, including rabeprazole sodium.
-
Contract Manufacturing Growth: The trend toward outsourcing APIs and formulations favors CMOs and enhances their market role.
Conclusion
A diverse array of global suppliers ensures the stable availability of rabeprazole sodium. Major Indian and Chinese manufacturers—such as Dr. Reddy’s, Alkem, Jiangsu Hengrui, Zhejiang Menovo, and others—play dominant roles due to their capacity, compliance standards, and cost competitiveness. Multinational corporations like Mylan, Teva, and GSK enhance supply resilience through extensive manufacturing and distribution networks. Understanding the capabilities, regulatory status, and regional strengths of these suppliers is crucial for pharmaceutical companies aiming for secure procurement and global market expansion.
Key Takeaways
- The primary suppliers of rabeprazole sodium are predominantly based in India and China, supported by a few global pharmaceutical companies.
- Regulatory compliance (GMP, FDA, EMA approvals) is critical for supplier credibility and market access.
- Diversification of suppliers reduces risk amid geopolitical and supply chain disruptions.
- Contract manufacturing organizations are increasingly vital for flexible and scalable supply chains.
- Staying abreast of emerging manufacturing trends and regulatory shifts enhances procurement strategies.
FAQs
1. How does supplier quality impact the procurement of rabeprazole sodium?
Supplier quality directly affects drug efficacy, regulatory approval, and market access. Suppliers with GMP certification and regulatory approvals (FDA, EMA) ensure consistent quality, reducing risk of recalls and compliance issues.
2. What are the primary regions supplying rabeprazole sodium globally?
India and China dominate API manufacturing for rabeprazole sodium, supported by multinational corporations operating in Europe and North America.
3. How do geopolitical factors influence the supply chain for rabeprazole sodium?
Trade tensions, tariffs, and export restrictions can disrupt supply chains, prompting companies to diversify supplier bases and invest in regional manufacturing capacity.
4. Are there regulatory differences between suppliers in India and China?
While both countries have established GMP standards, regulatory approval status—such as US FDA clearance—varies by manufacturer and is crucial for export to stringent markets.
5. What role do contract manufacturing organizations play in the rabeprazole sodium supply?
CMOs offer flexible, cost-efficient production solutions, allowing pharmaceutical companies to scale supply, ensure regulatory compliance, and minimize risks associated with single-source dependencies.
Sources:
[1] International Pharmaceutical Regulators Forum (IPRF) - API Manufacturing Standards
[2] U.S. FDA Drug Establishments Database
[3] European Medicines Agency (EMA) Approved APIs Listing
[4] Market research reports on gastrointestinal API producers
[5] Company websites and corporate disclosures
More… ↓
