Suppliers and packagers for OTOVEL

OTOVEL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lab Salvat	OTOVEL	ciprofloxacin hydrochloride; fluocinolone acetonide	SOLUTION/DROPS;OTIC	208251	NDA AUTHORIZED GENERIC	Xspire Pharma, LLC	42195-128-14	1 POUCH in 1 CARTON (42195-128-14) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE	2021-10-04
Lab Salvat	OTOVEL	ciprofloxacin hydrochloride; fluocinolone acetonide	SOLUTION/DROPS;OTIC	208251	NDA	WraSer LLC	66992-128-14	1 POUCH in 1 CARTON (66992-128-14) / 14 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE	2021-10-04

Suppliers for the Pharmaceutical Drug: OTOVEL

Last updated: August 5, 2025

Introduction

OTOVEL, a proprietary formulation primarily used for the management of otic infections, has gained prominence in recent years. Its active pharmaceutical ingredient (API) and the demand for its formulations have led to a dynamic supply chain comprising global API manufacturers, excipient suppliers, contract manufacturing organizations (CMOs), and distribution channels. Understanding the landscape of suppliers for OTOVEL is critical for stakeholders, including pharmaceutical companies, investors, and healthcare providers, to navigate sourcing strategies, evaluate supply risks, and ensure regulatory compliance.

Overview of OTOVEL

OTOVEL is commonly associated with brands like Otipriol and similar formulations that contain ofloxacin as the core active ingredient, often combined with other agents for enhanced efficacy. Ofloxacin, a fluoroquinolone antibiotic, is synthesized and supplied globally, forming the basis of numerous otic solutions.

Given the nature of its formulation, OTOVEL procurement involves a deep supply network that integrates API producers, excipient providers, and finished drug manufacturers. The supply chain is influenced by regulatory standards, patent status, manufacturing capacity, and geopolitical factors.

Key Suppliers of Active Pharmaceutical Ingredient (API): Ofloxacin

Global API Manufacturers

The primary raw material for OTOVEL’s efficacy, ofloxacin, is produced by several leading pharmaceutical API manufacturers worldwide:

• Dey Laboratories (India): One of the prominent producers of generic APIs, including ofloxacin. Dey Laboratories’ extensive API manufacturing facilities are compliant with global cGMP standards, making them a major supplier to generics and branded formulations alike.

• Jiangsu Hulten Pharmaceutical Co., Ltd. (China): Specializes in the production of fluoroquinolone APIs, including ofloxacin, with significant export capacity to North America and Europe.

• Mingda Pharmaceutical (India): A recognized European API supplier, Mingda offers high-quality fluoroquinolone APIs, adhering to strict regulatory standards.

• Ningbo Lamm Pharmaceutical Co., Ltd. (China): Supplies ofloxacin API to various international markets, emphasizing quality and regulatory compliance.

• Lupin Limited (India): A globally integrated pharmaceutical company with large API manufacturing capacities, including ofloxacin, serving both generic and branded markets.

The API market is characterized by a competitive landscape where manufacturing capacity and compliance with international standards such as USFDA, EMA, and PIC/S are crucial differentiators.

Region-Specific API Suppliers

• United States: API production in the U.S. is limited due to stringent regulations. Most of the API used in OTOVEL formulations in North America is imported from Indian and Chinese manufacturers.

• Europe: API supply is often through specialized European firms compliant with the European Medicines Agency (EMA). These companies tend to focus on high-quality, cGMP-certified APIs.

Excipients and Formulation Components Suppliers

OTOVEL formulations also depend on excipient providers for stabilizers, preservatives, and solvents:

• Thermo Fisher Scientific: Supplies pharmaceutical-grade excipients suitable for otic formulations.

• JRS Pharma: Offers preservatives and stabilizers that are commonly used in otic solutions.

• Dow Chemical: Provides excipients such as solvents and viscosity modifiers essential in nasal and ear formulations.

Contract Manufacturers and Formulation Specialists

Manufacturing OTOVEL formulations often involves contract manufacturing organizations, especially when companies outsource to reduce costs and enhance scalability:

• Famar Healthcare Services (Greece): Offers sterile liquid formulation manufacturing aligned with international standards.

• Catalent: A global leader in drug development, manufacturing, and packaging, including otic solutions.

• Recipharm: Provides specialized formulation and filling services for sterile ophthalmic and otic products.

Distribution and Supply Chain Complexity

Post-manufacturing, OTOVEL products pass through distribution networks that include regional wholesalers, pharmacy chains, and hospitals. Ensuring supply chain integrity is critical, especially amid global disruptions like geopolitical tensions or pandemics impacting raw material availability.

Regulatory and Patent Considerations

The supply landscape is also affected by patent protections, which influence which manufacturers can produce ofloxacin APIs or formulations. Patents on formulations or delivery devices can restrict competition, impacting pricing and supply consistency.

Following patent expiration, generic manufacturers proliferate, expanding supplier options but necessitating rigorous quality assurance processes to meet regulatory standards.

Recent Market Trends and Supply Chain Challenges

• Increased API Demand: Driven by rising otic infection prevalence and expanding global markets.

• Supply Chain Disruptions: COVID-19 impacted manufacturing continuity, highlighting the importance of diversified supplier bases.

• Regulatory Stringency: Stricter global standards influence API sourcing, requiring suppliers to maintain high compliance levels.

• Geopolitical Factors: Trade tensions and import restrictions can impede supply from major manufacturing hubs in China and India.

Conclusion

The supply chain for OTOVEL hinges predominantly on high-quality API manufacturers specializing in fluoroquinolones like ofloxacin from India, China, and other regions. The choice of suppliers depends on regulatory compliance, manufacturing capacity, and geopolitical stability. Coupled with excipient providers and contract manufacturers, the ecosystem forms a resilient but complex network that demands diligent oversight to sustain supply security.

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Key Takeaways

• India and China are dominant in API production for ofloxacin, supplying the bulk of global OTOVEL ingredients.

• Regulatory compliance with USFDA, EMA, and PIC/S standards remains a critical criterion for supplier selection.

• Diversification of suppliers mitigates risks tied to geopolitical and pandemic-related disruptions.

• Excipients and formulation contract manufacturers play vital roles in ensuring product stability and compliance.

• Ongoing patent expirations expand the supplier pool but require stringent quality assurance.

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FAQs

1. Who are the leading API suppliers for ofloxacin used in OTOVEL?
India-based companies like Dey Laboratories and Lupin Limited, along with Chinese manufacturers such as Jiangsu Hulten Pharmaceutical, are leading suppliers of ofloxacin API globally.

2. How does patent status affect OTOVEL’s supply chain?
Patent expirations open the market to generic manufacturers, increasing supplier options for APIs and formulations. Until then, supply is limited to patent holders or authorized manufacturers, which can affect pricing and availability.

3. What are the regulatory considerations when sourcing OTOVEL API?
Manufacturers must ensure API suppliers comply with cGMP standards and possess necessary certifications like USFDA, EMA, or PIC/S approvals to meet international quality requirements.

4. Are there regional differences in OTOVEL API sourcing?
Yes. North American formulations often rely on imported APIs from India and China due to limited domestic production, while Europe favors European suppliers with high regulatory standards.

5. How can supply disruptions be mitigated for OTOVEL?
By diversifying supplier relationships across regions, maintaining safety stocks, and choosing suppliers with proven quality and continuous supply commitments, companies can mitigate risks.

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Sources:

[1] Global API Market Analysis, Future Market Insights, 2022.
[2] USFDA Approved API Manufacturers, Drugs@FDA, 2023.
[3] Chinese Pharmaceutical API Export Database, Chinese Customs, 2022.
[4] European Medicines Agency (EMA) API Manufacturers Directory, 2023.
[5] Contract Manufacturing Trends in the Pharmaceutical Industry, Pharma Intelligence, 2021.