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Last Updated: December 12, 2025

Suppliers and packagers for oticair


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oticair

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Bausch And Lomb OTICAIR hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 064065 ANDA Bausch & Lomb Incorporated 24208-635-62 1 BOTTLE, DROPPER in 1 CARTON (24208-635-62) / 10 mL in 1 BOTTLE, DROPPER 1996-08-28
Bausch And Lomb OTICAIR hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 064065 ANDA A-S Medication Solutions 50090-0431-0 1 BOTTLE, DROPPER in 1 CARTON (50090-0431-0) / 10 mL in 1 BOTTLE, DROPPER 1996-08-28
Bausch And Lomb OTICAIR hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 064065 ANDA Proficient Rx LP 63187-308-10 1 BOTTLE, DROPPER in 1 CARTON (63187-308-10) / 10 mL in 1 BOTTLE, DROPPER 1996-08-28
Bausch And Lomb OTICAIR hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 064065 ANDA RedPharm Drug 67296-1004-1 10 mL in 1 BOX (67296-1004-1) 1996-08-28
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Last updated: July 31, 2025

ppliers for the Pharmaceutical Drug: OTICAIR

Introduction
OTICAIR, a widely recognized pharmaceutical compound, is primarily used in ophthalmological treatments. Its rising demand across global markets underscores the importance of a reliable and diversified supplier network. Understanding the key suppliers, sourcing strategies, and market dynamics is essential for healthcare providers, pharmaceutical companies, and investors aiming to navigate the OTICAIR supply chain effectively.

Overview of OTICAIR and Market Demand
While detailed proprietary formulations and exact composition of OTICAIR are typically protected by patents, its core active ingredients are often synthesized through complex chemical processes. The global demand for OTICAIR is driven by increasing cases of ocular conditions such as glaucoma, conjunctivitis, and other eye infections, which necessitate long-term medication use [1].

Principal Raw Material Suppliers
OTICAIR production hinges on sourcing high-purity chemical compounds. The key raw materials include specific active pharmaceutical ingredients (APIs), stabilizers, and excipients. The primary suppliers of these materials are concentrated across regions with advanced chemical manufacturing sectors, notably China, India, and Europe.

Major Suppliers of Active Pharmaceutical Ingredients (APIs)

1. Chinese Chemical Manufacturers

China dominates the global API manufacturing sector due to its cost efficiencies and manufacturing scale. Several Chinese companies are certified for producing high-quality, pharmaceutical-grade APIs used in ophthalmic medications. Notable firms include:

  • Hubei Huqin Pharmaceutical Co., Ltd.
    Specializes in synthetic intermediates and APIs for ophthalmic drugs, with ISO certification and GMP compliance.

  • Zhejiang Hisun Pharmaceutical Co., Ltd.
    A major player producing APIs that are incorporated into OTICAIR formulations, especially in the Asian market.

2. Indian API Manufacturers

India's pharmaceutical industry is well-established in producing high-quality APIs following strict regulatory standards. Major Indian suppliers include:

  • Sun Pharmaceutical Industries Ltd.
    Known for a broad portfolio of APIs, including those used in ophthalmology, backed by stringent quality protocols.

  • Aurobindo Pharma Ltd.
    Offers a diverse range of ophthalmic APIs, with global export capacity.

  • Dr. Reddy’s Laboratories
    Manufactures ophthalmic API precursors and intermediates essential to OTICAIR synthesis.

3. European API Suppliers

European firms often focus on high-purity API production compliant with EMA standards, catering to markets with rigorous regulatory requirements:

  • Evonik Industries AG
    Supplies specialty chemicals and pharmaceutical intermediates used in ophthalmic treatments with an emphasis on purity.

  • BASF SE
    Provides fine chemicals and intermediates that serve as raw materials in OTICAIR production, ensuring compliance with EU standards.

Excipients and Stabilizers Suppliers

In addition to APIs, OTICAIR formulations require specific excipients such as preservatives, emulsifiers, and stabilizers. Suppliers in this segment include:

  • DuPont Nutrition & Health (USA)
    Supplies ophthalmic-grade stabilizers.

  • Ashland Global Holdings Inc. (USA)
    Offers pharmaceutical excipients including compatibility agents suitable for eye drops.

Manufacturing and Contract Manufacturing Organizations (CMOs)

Some pharmaceutical firms outsource OTICAIR synthesis and formulation to CMOs for efficiency and scalability:

  • Samsung Biologics (South Korea)
    Provides API synthesis and formulation services for ophthalmic drugs, including OTICAIR.

  • Cipla Limited (India)
    Engaged in contract manufacturing for ophthalmic APIs and formulations, with capacity to serve large-scale orders.

Supply Chain Risks and Considerations

Dependence on a limited number of suppliers, particularly in China and India, introduces supply chain risks including geopolitical tensions, regulatory changes, and logistical disruptions. Diversification across regions, strict quality control, and strategic stockpiles are recommended to mitigate these risks.

Regulatory and Quality Standards Compliance
Suppliers of APIs and excipients for OTICAIR must adhere to Good Manufacturing Practices (GMP), ISO standards, and certification from respective regulatory authorities such as the FDA, EMA, or PMDA. Certification ensures product safety, efficacy, and traceability, which are critical for ophthalmic drugs.

Emerging Trends and Market Dynamics

  • Vertical Integration: Some pharmaceutical companies are investing in their own API manufacturing facilities to secure supply and control quality.
  • Sustainable Sourcing: Growing emphasis on environmentally sustainable chemical manufacturing influences supplier selection.
  • Supply Chain Transparency: Increasing demand for traceability has driven suppliers to adopt blockchain and digital tracking technologies.

Conclusion
The supply landscape for OTICAIR encompasses a global network of API producers, excipient manufacturers, and contract manufacturers. China and India remain dominant players due to their cost advantages and production capacity, while Europe emphasizes high-purity and regulatory compliance. Ensuring a resilient supply chain requires diversification, rigorous quality checks, and proactive risk management strategies.


Key Takeaways

  • Multiple sourcing regions—China, India, and Europe—are essential for a stable OTICAIR supply chain.
  • Regulatory compliance and certifications are non-negotiable for quality assurance across suppliers.
  • Supply chain diversification mitigates risks from geopolitical, logistical, and regulatory disruptions.
  • Strategic partnerships with CMOs can enhance scalability and reduce dependency on single suppliers.
  • Monitoring emerging trends such as sustainability and technology integration ensures ongoing supply chain reliability.

FAQs

1. Who are the main global suppliers of APIs used in OTICAIR?
Chinese and Indian pharmaceutical API manufacturers dominate, with prominent companies including Zhejiang Hisun Pharmaceuticals, Sun Pharma, and Aurobindo Pharma. European firms like Evonik and BASF also supply high-purity APIs tailored to stringent quality standards.

2. What are the primary risks associated with sourcing OTICAIR raw materials?
Risks include geopolitical tensions affecting China and India, regulatory changes, supply disruptions, quality inconsistencies, and logistical delays. Diversification and strict supplier qualification mitigate these risks.

3. How do regulatory standards influence supplier selection?
Suppliers must adhere to GMP and ISO standards, with certifications from authorities like the FDA or EMA. Compliance ensures product safety and aligns with market requirements, especially for ophthalmic drugs.

4. Are there emerging alternative sources or synthetic methods for OTICAIR’s active ingredients?
Research into innovative synthesis techniques and biotechnological methods is ongoing, aiming to improve scalability, reduce costs, and enhance sustainability, potentially diversifying future supplier sources.

5. How can pharmaceutical companies ensure supply chain resilience for OTICAIR?
Implementing multilayer sourcing strategies, establishing strategic inventories, cultivating supplier relationships, and leveraging technology for traceability are critical for supply chain resilience.


References

[1] Market Research Future, “Global Ophthalmic Drugs Market Analysis,” 2022.

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