Suppliers and packagers for generic pharmaceutical drug: OMEPRAZOLE MAGNESIUM

OMEPRAZOLE MAGNESIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma Ltd	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	213201	ANDA	Aurohealth LLC	58602-837-05	1 BOTTLE in 1 CARTON (58602-837-05) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2023-04-28
Dr Reddys Labs Ltd	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	078878	ANDA	Walgreens Company	0363-0042-01	3 BOTTLE in 1 CARTON (0363-0042-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2015-09-01
Dr Reddys Labs Ltd	OMEPRAZOLE MAGNESIUM	omeprazole magnesium	CAPSULE, DELAYED RELEASE;ORAL	078878	ANDA	Walgreens Company	0363-0042-27	2 BOTTLE in 1 CARTON (0363-0042-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE	2015-09-01

Suppliers for the Pharmaceutical Drug: Omeprazole Magnesium

Last updated: July 29, 2025

Introduction

Omeprazole magnesium, a proton pump inhibitor (PPI), is widely used to treat gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Its global demand, driven by increasing incidences of acid-related disorders, necessitates a robust and diverse supply chain. This article provides a comprehensive overview of key suppliers manufacturing and distributing omeprazole magnesium, highlighting their manufacturing capabilities, geographic presence, and market significance. Understanding these suppliers is critical for stakeholders seeking reliable sourcing, quality assurance, and competitive pricing in the pharmaceutical supply chain.

Global Manufacturing Landscape of Omeprazole Magnesium

Omeprazole magnesium production relies on complex chemical synthesis, requiring high standards for safety, purity, and stability. Suppliers span across North America, Europe, and Asia, with key players often integrated within larger generic pharmaceutical manufacturing conglomerates. The synthesis process involves multiple steps, including the preparation of active pharmaceutical ingredients (APIs) and formulation, emphasizing the need for specialized chemical expertise and regulatory compliance.

Leading Suppliers of Omeprazole Magnesium

1. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

Overview: Zhejiang Huahai is a prominent Chinese pharmaceutical manufacturer with a significant footprint in producing omeprazole magnesium. The company offers high-quality APIs and finished formulations, adhering to stringent Good Manufacturing Practice (GMP) standards.

Capabilities: Zhejiang Huahai ensures large-scale production leveraging advanced synthesis technology, enabling competitive pricing and reliable supply chains. The firm is certified by the Food and Drug Administration (FDA) of China and complies with international standards, facilitating export to global markets.

Market Significance: As one of the leading API suppliers globally, Zhejiang Huahai has established a reputation for quality and volume, serving both domestic and international pharmaceutical companies.

2. Jiangsu Hengrui Medicine Co., Ltd. (China)

Overview: Jiangsu Hengrui holds a robust portfolio of active pharmaceutical ingredients, including omeprazole magnesium. The company emphasizes research and development (R&D) to optimize synthesis pathways and ensure high purity levels.

Capabilities: Equipped with state-of-the-art facilities, Hengrui supplies API batches that meet international regulatory standards, including the U.S. FDA and European Medicines Agency (EMA). Their global distribution network ensures broader market reach.

Market Significance: Hengrui's strategic focus on R&D and compliance helps solidify its position as a preferred supplier for multinational pharmaceutical companies seeking consistent quality.

3. Dr. Reddy's Laboratories (India)

Overview: Dr. Reddy's is an Indian multinational pharmaceutical company with extensive capabilities in producing omeprazole magnesium locally and exporting to global markets. Their API manufacturing facilities are certified by multiple regulatory agencies.

Capabilities: Dr. Reddy’s leverages integrated manufacturing processes and quality management systems aligned with global standards. The company supplies APIs and finished dosage forms, facilitating streamlined procurement for generic drug manufacturers.

Market Significance: With a strong presence in North America and Europe, Dr. Reddy's balances cost-effectiveness with high-quality production, making it a strategic supplier in the global omeprazole magnesium market.

4. Teva Pharmaceutical Industries Ltd. (Israel)

Overview: Teva is a leading global generic pharmaceutical manufacturer and a key supplier of omeprazole magnesium API and generics. The company maintains multiple manufacturing sites with comprehensive quality controls.

Capabilities: Teva invests heavily in manufacturing infrastructure, ensuring compliance with worldwide GMP standards and maintaining a competitive edge through innovation. Its extensive distribution network enables rapid global supply.

Market Significance: As a pioneer in the generic drug industry, Teva’s globally recognized quality standards make it a preferred supplier for large-scale pharmaceutical companies.

5. Sahara Pharmaceutical Industries Ltd. (India)

Overview: Sahara Pharmaceutical specializes in the synthesis of high-grade APIs, including omeprazole magnesium, serving both regional and international markets.

Capabilities: The firm operates multiple GMP-certified manufacturing units and emphasizes quality assurance and scalable production. It has achieved rigorous regulatory approvals, including USFDA and EU GMP certifications.

Market Significance: Sahara's strategic focus on quality and compliance has elevated its standing among API suppliers for multinational pharma companies.

Regional Considerations and Market Dynamics

The geographic distribution of suppliers influences supply chain resilience, pricing, and regulatory compliance. China and India dominate as low-cost manufacturing hubs, providing significant volume and competitive pricing. European and North American suppliers generally emphasize stricter regulatory adherence and consistent quality, often serving markets with higher regulatory stringency.

Supply chain disruptions are increasingly mitigated through diversification of sourcing strategies, with companies seeking multiple suppliers across regions to reduce dependency and safeguard against geopolitical or logistic challenges.

Regulatory and Quality Standards

Suppliers must adhere to a range of regulatory standards, including cGMP, FDA, EMA, and WHO certifications, ensuring safety, quality, and efficacy of omeprazole magnesium. Suppliers with international certifications are preferred, particularly for markets like the United States and Europe.

Quality assurance involves rigorous testing for impurities, stability, and bioavailability, critical in maintaining regulatory compliance and drug efficacy.

Market Trends Influencing Supplier Selection

• Cost Competitiveness: In the context of worldwide price pressures, Chinese and Indian suppliers offer highly competitive API costs, often driving procurement strategies.
• Regulatory Compliance: Suppliers with proven compliance and a history of regulatory inspections cultivate trust, especially among multinational corporations.
• Supply Chain Flexibility: Suppliers capable of scaling production rapidly and maintaining consistent supply are increasingly vital amid global disruptions.
• Innovation and R&D: Companies investing in process optimization and sustainable manufacturing practices are gaining a competitive advantage.

Conclusion

A robust supply chain for omeprazole magnesium involves integrating diverse geographic sources to balance cost, quality, and regulatory compliance. Major suppliers such as Zhejiang Huahai, Jiangsu Hengrui, Dr. Reddy’s, Teva, and Sahara Pharmaceuticals exemplify the key players that ensure global availability. Stakeholders must evaluate supplier capabilities holistically, considering regulatory track record, manufacturing capacity, geographic diversification, and cost-efficiency to mitigate risks and ensure uninterrupted supply.

---

Key Takeaways

• Diversify sourcing: Combining suppliers from China, India, and developed regions enhances resilience.
• Prioritize regulatory compliance: Certifications like FDA, EMA, and WHO are critical for market access.
• Evaluate manufacturing capacity and quality controls: Ensure suppliers can meet demand and quality standards.
• Monitor geopolitical and logistic risks: Geographic diversification reduces vulnerability to regional disruptions.
• Invest in supplier relationships: Long-term partnerships foster stability and quality assurance.

---

FAQs

Q1: What are the primary regions supplying omeprazole magnesium globally?
A: The main regions are China, India, Europe, and North America, with China and India leading due to cost advantages, while Europe and North America focus on strict regulatory compliance.

Q2: How do regulatory certifications influence supplier selection?
A: Certifications such as cGMP, FDA, EMA, and WHO attest to quality and regulatory compliance, essential for legal export and acceptance in regulated markets.

Q3: Why is supplier diversification crucial for omeprazole magnesium?
A: Diversification mitigates risks from regional disruptions, geopolitical issues, and supply chain bottlenecks, ensuring consistent drug availability.

Q4: What qualities should a pharmaceutical company look for in an omeprazole magnesium supplier?
A: Key qualities include manufacturing capacity, regulatory adherence, quality control, cost competitiveness, and the ability to supply reliably at scale.

Q5: Are there emerging suppliers or regions influencing the omeprazole magnesium market?
A: Yes, regions such as Southeast Asia are increasingly gaining prominence, driven by rising manufacturing capabilities, competitive costs, and expanding regulatory acceptance.

---

References

1. [1] Zhejiang Huahai Pharmaceutical Co., Ltd. Company profile and manufacturing capacity.
2. [2] Jiangsu Hengrui Medicine Co., Ltd. Corporate overview and API production details.
3. [3] Dr. Reddy’s Laboratories API manufacturing and global regulatory compliance.
4. [4] Teva Pharmaceutical Industries Ltd. Global API & generics manufacturing overview.
5. [5] Market analysis reports on global omeprazole magnesium supply chain and regional dynamics.