Suppliers and packagers for generic pharmaceutical drug: mometasone furoate; olopatadine hydrochloride

mometasone furoate; olopatadine hydrochloride

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746	NDA	HIKMA SPECIALTY USA INC.	59467-700-27	12 CARTON in 1 BOX (59467-700-27) / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAY	2022-08-15
Glenmark Speclt	RYALTRIS	mometasone furoate; olopatadine hydrochloride	SPRAY, METERED;NASAL	211746	NDA	HIKMA SPECIALTY USA INC.	59467-700-84	12 CARTON in 1 BOX (59467-700-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY	2022-08-15

Suppliers for the Pharmaceutical Drugs: Mometasone Furoate and Olopatadine Hydrochloride

Last updated: July 29, 2025

Introduction

The global pharmaceutical landscape relies heavily on a diversified network of suppliers for key active pharmaceutical ingredients (APIs). For drugs such as Mometasone Furoate and Olopatadine Hydrochloride, which are widely utilized in the treatment of allergic rhinitis, atopic dermatitis, and other inflammatory conditions, establishing a reliable supply chain is crucial for medicine manufacturers, healthcare providers, and patients. This article explores the primary API suppliers, manufacturing hubs, and market trends shaping supply dynamics for these medications.

Overview of Mometasone Furoate and Olopatadine Hydrochloride

Mometasone Furoate

Mometasone Furoate is a potent topical corticosteroid used predominantly in nasal sprays (e.g., Nasonex) and inhalation formulations. It exerts anti-inflammatory effects by suppressing the migration of inflammatory cells and reversing capillary permeability.

Olopatadine Hydrochloride

Olopatadine Hydrochloride is an antihistamine, primarily available as nasal spray and ophthalmic drops, used for allergic rhinoconjunctivitis and other allergic conditions. It functions by selectively antagonizing H1 histamine receptors and stabilizing mast cells.

Global Supply Chain Infrastructure

Given the complexity of manufacturing APIs, many countries have developed specialized hubs that supply pharmaceutical companies worldwide. Historically, India and China dominate the production of both Mometasone Furoate and Olopatadine Hydrochloride due to their extensive chemical manufacturing capacities, regulatory frameworks, and cost-competitiveness.

Major Suppliers of Mometasone Furoate

1. China-Based Manufacturers

Chinese companies are leading suppliers for Mometasone Furoate, leveraging established chemical synthesis expertise.

• Shanghai Desano Chemical Co.
  Specializes in corticosteroid APIs, including mometasone derivatives, offering both bulk quantities and customized specifications.

• Huaian Sine Pharmaceutical Co., Ltd.
  A significant player in corticosteroid API manufacturing, with export capabilities to European and North American markets.

• Shandong Xinhua Pharmaceutical
  Involved in the production of corticosteroid APIs with global distribution channels.

2. Indian Suppliers

India’s pharmaceutical industry has developed robust expertise in corticosteroid APIs.

• Bharat Rasayan Ltd.
  Produced various corticosteroid APIs, including mometasone, with a focus on quality standards compliant with international regulations.

• Amsal Pharmaceutical Ltd.
  Offers mometasone furoate with compliance to Good Manufacturing Practice (GMP) standards.

3. Other Notable Suppliers

While Chinese and Indian sources dominate, smaller manufacturers in Europe and North America provide high-purity APIs for niche markets and specialized formulations.

• Genentech (USA)—though primarily a pharmaceutical company, it historically engaged in API synthesis for the corticosteroid class (though less so currently).

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Major Suppliers of Olopatadine Hydrochloride

1. Chinese Manufacturers

Chinese firms are the primary suppliers globally, offering cost-effective Olopatadine Hydrochloride.

• Jiangsu Hengrui Medicine Co., Ltd.
  A leading pharmaceutical company manufacturing olopatadine API with international certification.

• Shandong LianBa Pharmaceutical Co., Ltd.
  Provides pharmaceutical-grade olopatadine hydrochloride, exported to various regions.

2. Indian Manufacturers

India’s API producers for olopatadine have expanded their capacities over recent years.

• Granules India Limited
  Produces olopatadine API for domestic use and exports.

• Sun Pharma Advanced Research Company (SPARC)
  Involved in the synthesis of olopatadine as part of its diversified API portfolio.

3. European and North American Suppliers

While less dominant, some European companies operate in the high-purity niche, examples include:

• EU-GMP Certified Suppliers—such as Novartis and GSK, which sometimes produce high-grade olopatadine for formulations.

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Market Dynamics and Trends

1. Supply Chain Concentration Risks

The heavy reliance on China and India introduces supply chain vulnerabilities, including geopolitical tensions, regulatory changes, and manufacturing disruptions, as evidenced during the COVID-19 pandemic [1].

2. Regulatory Developments

Regulatory agencies like the US FDA and EMA increasingly scrutinize API manufacturing facilities. Suppliers expanding compliance have a competitive advantage, leading to diversification efforts among pharmaceutical firms [2].

3. Contract Manufacturing & OEMs

Contract manufacturing organizations (CMOs) and original equipment manufacturers (OEMs) actively contract with API suppliers to mitigate risks and ensure supply continuity. Companies such as Aenova and PCI Pharma Services often manage complex API sourcing.

4. Trends Toward Sustainability and Quality

Manufacturers are adopting sustainable practices and ensuring Good Manufacturing Practice (GMP) compliance to meet stricter quality standards, which influences supplier selection.

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Due Diligence in Supplier Selection

Pharmaceutical firms prioritize:

• Regulatory compliance (GMP, FDA, EMA approvals)
• Production capacity and scalability
• Quality control measures
• Supply chain transparency and logistics
• Cost and contractual flexibility

Engagement with suppliers involves thorough auditing and ongoing monitoring to uphold quality standards and supply reliability.

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Conclusion

Securing high-quality, reliable suppliers for Mometasone Furoate and Olopatadine Hydrochloride remains a critical component of pharmaceutical manufacturing. The global market is highly concentrated in China and India, but diversification and stringent supplier qualification processes are vital to mitigate risks and meet evolving regulatory standards.

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Key Takeaways

• China and India dominate the API supply chain for both Mometasone Furoate and Olopatadine Hydrochloride due to cost and manufacturing expertise.
• Supply chain diversification minimizes risk amid geopolitical and regulatory challenges.
• Regulatory compliance and quality assurance are critical factors in selecting and maintaining suppliers.
• Global regulatory developments are influencing sourcing strategies, emphasizing sustainability, transparency, and GMP adherence.
• Contract manufacturing organizations are increasingly playing a central role in AP supply chain management for these APIs.

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FAQs

1. What are the primary factors influencing the choice of API suppliers for Mometasone Furoate and Olopatadine Hydrochloride?

Supply chain reliability, regulatory compliance, product quality, manufacturing capacity, and cost are essential criteria.

2. Are there any North American or European suppliers for these APIs?

While China and India dominate, some European and North American firms provide high-purity APIs, mainly for niche markets, but at higher costs.

3. How has the COVID-19 pandemic affected API supply chains for these drugs?

Disruptions led to increased supply chain risks, prompting companies to diversify suppliers and prioritize contingency planning.

4. What regulatory considerations are important when sourcing APIs from Chinese or Indian manufacturers?

Manufacturers must demonstrate GMP compliance, regulatory approvals (FDA, EMA), and robust quality control processes.

5. Is there a trend toward environmentally sustainable API manufacturing?

Yes, pharmaceutical companies increasingly prefer suppliers adopting sustainable practices adhering to environmental regulations.

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References

[1] World Health Organization. (2021). 2021 Report on Global Pharmaceutical Supply Chains.
[2] U.S. Food and Drug Administration. (2022). Guidance on API Manufacturing and Inspection.