Suppliers and packagers for generic pharmaceutical drug: loteprednol etabonate; tobramycin

loteprednol etabonate; tobramycin

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	ZYLET	loteprednol etabonate; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050804	NDA	Bausch & Lomb Incorporated	24208-358-01	1 BOTTLE, DROPPER in 1 CARTON (24208-358-01) / 1 mL in 1 BOTTLE, DROPPER	2004-12-14
Bausch And Lomb	ZYLET	loteprednol etabonate; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050804	NDA	Bausch & Lomb Incorporated	24208-358-05	1 BOTTLE, DROPPER in 1 CARTON (24208-358-05) / 5 mL in 1 BOTTLE, DROPPER	2004-12-14
Bausch And Lomb	ZYLET	loteprednol etabonate; tobramycin	SUSPENSION/DROPS;OPHTHALMIC	050804	NDA	Bausch & Lomb Incorporated	24208-358-10	1 BOTTLE, DROPPER in 1 CARTON (24208-358-10) / 10 mL in 1 BOTTLE, DROPPER	2004-12-14

Suppliers for the Pharmaceutical Drugs: Loteprednol Etabonate and Tobramycin

Last updated: July 29, 2025

Introduction

The pharmaceutical industry demands precise sourcing of active pharmaceutical ingredients (APIs), especially for ophthalmic and antimicrobial medications such as Loteprednol Etabonate and Tobramycin. These compounds serve critical functions — Loteprednol Etabonate as a corticosteroid used to treat inflammation, and Tobramycin as an aminoglycoside antibiotic targeting bacterial infections. Ensuring reliable suppliers for these APIs is essential for pharmaceutical companies to maintain product quality, regulatory compliance, and supply chain integrity. This article provides a comprehensive overview of the leading suppliers, their manufacturing capabilities, geographic distribution, and strategic considerations pertinent to sourcing these APIs.

Overview of Loteprednol Etabonate and Tobramycin

Loteprednol Etabonate

Developed as a soft corticosteroid, Loteprednol Etabonate is primarily utilized in ophthalmic formulations for reducing ocular inflammation with a favorable safety profile. Its unique ester-based structure allows rapid metabolism, thereby minimizing steroid-related side effects. It is typically produced through complex organic synthesis involving multiple steps of chemical transformations, requiring specialized expertise and manufacturing facilities.

Tobramycin

Tobramycin is an aminoglycoside antibiotic effective against a broad spectrum of Gram-negative and some Gram-positive bacteria. As a fermentation-derived antibiotic, Tobramycin is produced through microbial fermentation processes involving Streptomyces species. Its manufacturing demands fermentation capacity, purification processes, and strict quality controls to ensure consistency and safety.

Leading API Suppliers for Loteprednol Etabonate

1. Xian Janssen Pharmaceutical Ltd. (China)

A prominent manufacturer specializing in ophthalmic APIs, Xian Janssen produces Loteprednol Etabonate to meet global demand. The company's facilities are equipped with state-of-the-art synthesis and purification technologies, adhering to Good Manufacturing Practices (GMP). They supply both bulk APIs and finished dosage forms to CNS and global markets.

2. Ashland Specialties Inc. (USA)

Ashland has developed a niche in ophthalmic steroid APIs, including Loteprednol Etabonate. Their manufacturing facilities comply with international standards, and they focus on high-quality, consistent supply for pharmaceutical partners. Their strategic focus includes R&D collaborations on derivative development.

3. Liomont Laboratories (Mexico)

Liomont is expanding its API portfolio to include ophthalmic corticosteroids. Their production facilities are certified under FDA and WHO standards. Given their strategic geographical location, they serve North American and Latin American markets efficiently.

4. Fulford Ltd. (India)

Fulford offers pharmaceutical intermediates and APIs, including Loteprednol. Their extensive R&D pipeline and cost-effective manufacturing make them a significant player in emerging markets, providing competitive sourcing options for pharmaceutical companies.

5. Other Emerging Suppliers

Additional players such as Zhejiang Hisun Pharmaceutical (China) and SK Biotek (South Korea) are developing capacities for ophthalmic steroids, including Loteprednol, focusing on expanding their export reach to global markets.

Key Suppliers for Tobramycin

1. Lupin Limited (India)

Lupin is a leading global API manufacturer with robust fermentation and purification processes for Tobramycin. Their manufacturing plants are GMP-compliant, and they export to North America, Europe, and Asia, maintaining regulatory approvals from agencies including the FDA and EMA.

2. Wockhardt Ltd. (India)

Wockhardt manufactures Tobramycin as part of its antimicrobial API portfolio. With a focus on high-purity fermentation, Wockhardt supplies both bulk drug segments and finished intermediates to global markets.

3. Hikma Pharmaceuticals (UK/Jordan)

Hikma produces Tobramycin in addition to other antibiotics, leveraging integration of fermentation and chemical synthesis. The company emphasizes robust quality assurance aligned with international standards.

4. Teva Pharmaceutical Industries (Israel)

Teva’s API manufacturing facilities for Tobramycin serve both their generic pharmaceutical operations and external licensing partners. Their global footprint provides strategic access, especially for North American and European markets.

5. Fosun Pharma (China)

Fosun Pharma has expanded its antimicrobial manufacturing capabilities, including Tobramycin, with a focus on high-quality fermentation and compliance with international GMP standards.

Geographic and Regulatory Considerations

Most leading suppliers are based in India, China, and Israel, reflecting regional strengths in fermentation-based APIs and chemical synthesis. Regulatory rigor varies; suppliers with FDA or EMA approval are preferred for markets with strict regulatory oversight. Some Chinese and Indian manufacturers have achieved approvals or audits from regulatory agencies, enhancing credibility.

Strategic Sourcing Factors

Quality and Compliance

Achieving pharmaceutical-grade quality requires suppliers with ISO, GMP, and, where applicable, FDA or EMA certifications. Due diligence on regulatory track record, batch consistency, and quality control measures is crucial.

Capacity and Scalability

Suppliers must demonstrate the capacity for scalable production to meet fluctuating demand, especially during global health emergencies or supply chain disruptions.

Cost and Lead Times

Cost competitiveness remains a key factor; however, quality often outweighs cost. Lead times depend on the supplier’s production schedules and regulatory clearance processes.

Intellectual Property and Licensing

While APIs like Tobramycin and Loteprednol are generic compounds, some formulations may involve proprietary processes or licensing agreements. Contractual clarity on licensing and patent rights is essential.

Supply Chain Resilience

Diversification of suppliers across geographies mitigates risks. Building strategic partnerships with reliable, compliant manufacturers enhances supply chain stability.

Conclusion

The landscape for sourcing Loteprednol Etabonate and Tobramycin APIs is dominated by manufacturers in India, China, and select Western countries, each offering varied advantages in capacity, regulatory compliance, and cost. Pharmaceutical companies seeking stable supplies should prioritize suppliers with verified GMP certification, proven manufacturing capacity, and regulatory approvals aligned with target markets. Developing multiple sourcing channels and maintaining ongoing compliance assessments ensures resilience and continuity in the supply chain.

---

Key Takeaways

• Quality Above Cost: Ensure suppliers possess GMP, FDA, or EMA approvals for confidence in API quality and regulatory compliance.
• Supplier Diversification: Spread sourcing across multiple regions to reduce dependency risk amid geopolitical or logistical disruptions.
• Capacity Assessment: Confirm supplier capacity and scalability to meet production demands without compromising quality.
• Regulatory Transparency: Engage suppliers with well-documented compliance and transparent quality assurance processes.
• Market Trends: Emerging suppliers from India and China continue to expand their capacities for high-demand APIs like Loteprednol and Tobramycin.

---

FAQs

1. What are the primary regions for sourcing Loteprednol Etabonate?
India, China, the USA, and Mexico are prominent regions, with Indian and Chinese manufacturers leading due to large-scale fermentation and chemical synthesis capabilities.

2. How do I verify the regulatory compliance of API suppliers?
Request GMP certificates, regulatory filings, and audit reports. Preference should be given to suppliers with approvals from recognized authorities like the FDA, EMA, or WHO.

3. Are there strategic advantages to sourcing from Chinese manufacturers?
Yes. Chinese suppliers often offer competitive costs, high capacity, and growing regulatory compliance for APIs, though due diligence on quality standards remains essential.

4. What considerations are critical when sourcing Tobramycin?
Fermentation capacity, microbial strain quality, purification processes, and regulatory approvals are critical, given Tobramycin’s biological production pathway.

5. How can companies mitigate supply chain risks for these APIs?
Diversify supplier base across regions, establish strong quality agreements, regularly audit manufacturing facilities, and maintain inventories to buffer against disruptions.

---

References

1. International Pharmaceutical Regulators Forum (IPRF). API Regulatory Requirements. 2022.
2. Global Industry Analysts Inc. Pharmaceutical Active Ingredients: A Global Market Overview. 2021.
3. PubChem. Loteprednol Etabonate. National Center for Biotechnology Information.
4. World Health Organization. Guidelines for Pharmaceutical API Manufacturing. 2020.
5. Pharmaceutical Technology. Emerging Trends in API Production. 2022.