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Suppliers and packagers for generic pharmaceutical drug: OFLOXACIN
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OFLOXACIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Allergan | OCUFLOX | ofloxacin | SOLUTION/DROPS;OPHTHALMIC | 019921 | NDA | Allergan, Inc. | 11980-779-05 | 1 BOTTLE, DROPPER in 1 CARTON (11980-779-05) / 5 mL in 1 BOTTLE, DROPPER | 1993-08-01 |
| Altaire Pharms Inc | OFLOXACIN | ofloxacin | SOLUTION/DROPS;OPHTHALMIC | 202692 | ANDA | Altaire Pharmaceuticals Inc. | 59390-140-05 | 5 mL in 1 BOTTLE, DROPPER (59390-140-05) | 2013-05-31 |
| Amneal | OFLOXACIN | ofloxacin | SOLUTION/DROPS;OPHTHALMIC | 211524 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1665-6 | 1 BOTTLE, DROPPER in 1 CARTON (69238-1665-6) / 10 mL in 1 BOTTLE, DROPPER | 2024-03-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ofloxacin
Introduction
Ofloxacin is a broad-spectrum fluoroquinolone antibiotic primarily used to treat bacterial infections related to the respiratory tract, urinary tract, skin, and soft tissues. Since its approval, ofloxacin has become an essential component in antimicrobial therapy, prompting significant demand across the pharmaceutical industry. Identifying reliable suppliers for ofloxacin involves examining the major manufacturing companies, regional production capacities, regulatory compliance, and global supply chain dynamics. This comprehensive overview discusses the leading suppliers of ofloxacin, their manufacturing footprints, and strategic considerations for procurement professionals.
Global Manufacturing Landscape of Ofloxacin
The global supply of ofloxacin hinges on a sophisticated network of pharmaceutical ingredient (API) manufacturers, many of which operate under strict regulatory standards such as cGMP (current Good Manufacturing Practice). Countries leading in API production—India, China, and certain European nations—dominate the market.
India:
India remains a key supplier for ofloxacin, home to numerous API manufacturers recognized for their cost efficiency, quality standards, and large production capacities. Companies like Aarti Drugs, Cipla, Ipca Laboratories, and Lupin are among the most prominent. Indian firms benefit from robust export infrastructure, favorable regulations, and established global distribution networks.
China:
Chinese pharmaceutical API companies also play a significant role. Firms such as Hubei Bailing Tech, Shenzhen Sunflower Pharmaceutical, and Zhejiang Taizhou Sunflower Pharmaceutical produce ofloxacin with significant volume and competitive pricing, orienting toward export markets.
Europe and the USA:
While European and American companies produce ofloxacin, their focus is often on finishing formulations or high-value, specialty APIs. European firms such as Sandoz and Teva sometimes supply ofloxacin APIs, primarily for regional markets, but their production capacities are generally smaller compared to Indian and Chinese counterparts.
Major API Suppliers for Ofloxacin
Below is a detailed listing of notable suppliers categorized regionally, emphasizing their manufacturing capacities, quality certifications, and market reach.
Indian Suppliers
1. Ipca Laboratories
A leading manufacturer with extensive expertise in fluoroquinolone APIs, including ofloxacin. Ipca’s facilities are certified with ISO standards, and the company supplies to global generics markets, with exports to over 100 countries.
2. Lupin Limited
Known for its sophisticated R&D and high-volume API manufacturing, Lupin offers high-quality ofloxacin APIs to both branded and generic markets. The company's manufacturing plants in India are approved by USFDA, EDQM, and other stringent regulators.
3. Aarti Drugs
Specialized in antibiotic APIs, Aarti Drugs maintains a robust production base with certifications such as WHO-GMP, serving both domestic and international markets with competitive pricing and quality assurance.
4. Alembic Pharmaceuticals
With a sizable API manufacturing footprint recognized by USFDA and EMA, Alembic supplies ofloxacin to various markets, emphasizing compliance with international quality standards.
Chinese Suppliers
5. Hubei Bailing Tech
A major Chinese API manufacturer with significant capacity in fluoroquinolones. The company exports to multiple continents and maintains compliance with cGMP and other global standards.
6. Zhejiang Taizhou Sunflower Pharmaceutical
Known for producing various antibiotics, including ofloxacin, the firm focuses on quality and cost-competitiveness, exporting primarily to Asia, Africa, and Latin America.
7. Shenzhen Sunflower Pharmaceutical Co., Ltd.
Specializes in API production, with extensive experience in fluoroquinolones. The manufacturer adheres to international certifications, and its APIs are used by multinational pharmaceutical companies.
European and US Suppliers
8. Sandoz (Novartis Group)
While primarily focused on finished dosage forms, Sandoz occasionally supplies APIs for specialized markets. Its stringent quality management makes it an option for high-end formulations.
9. Teva Pharmaceuticals
A global generics leader, Teva's API division supplies various antibiotics, including ofloxacin, often targeting the European and North American markets, emphasizing regulatory compliance.
Regulatory Certifications and Quality Assurance
Suppliers' credibility rests heavily on regulatory compliance. Leading manufacturers typically possess certifications such as USFDA approval, EUGMP (European Medicines Good Manufacturing Practice), ISO standards, and WHO-GMP compliance. These certifications affirm their ability to produce APIs that meet international safety, quality, and efficacy standards.
Quality control measures include rigorous in-process testing, validated manufacturing processes, stability testing, and third-party auditing, ensuring consistent product quality critical for international clients.
Supply Chain Dynamics and Strategic Sourcing
The supply of ofloxacin is sensitive to geopolitical factors, trade policies, and raw material availability. The ongoing global focus on antibiotic resistance and regulatory tightening can influence supply stability.
Key considerations for procurement include:
- Capacity and lead times: Large suppliers with integrated manufacturing tend to offer more reliable supplies.
- Pricing and competitiveness: Asian suppliers often offer lower costs due to scale and manufacturing efficiencies.
- Regulatory compliance: Choose suppliers with proven track records of quality and regulatory approvals.
- Logistics and export policies: Consider customs, tariffs, and international shipping reliability.
Procurement professionals should foster strategic partnerships with vetted suppliers, regularly audit manufacturing sites, and diversify sources to mitigate risks associated with supply disruptions.
Emerging Trends
The industry is witnessing a shift towards bioequivalent manufacturing, increased regulatory scrutiny, and a focus on sustainable practices. Suppliers investing in sustainable raw material sourcing, green manufacturing, and digitalized quality management systems are gaining preference.
Further, the growing importance of local manufacturing in North America and Europe might lead to the establishment of regional API production units to reduce dependency on Asian suppliers, thereby improving supply resilience.
Conclusion
The procurement landscape for ofloxacin APIs is predominantly characterized by a robust network of Indian and Chinese manufacturers, complemented by European and US suppliers catering to niche or regulated markets. The key to a resilient supply chain involves selecting suppliers with proven regulatory compliance, high manufacturing capacity, and reliable logistics. As demand continues to grow, especially in emerging markets, proactive sourcing strategies, supplier diversification, and emphasis on quality standards will be paramount.
Key Takeaways
- Indian and Chinese API manufacturers dominate the ofloxacin supply chain due to their scale, cost advantages, and regulatory compliance.
- Leading suppliers such as Ipca, Lupin, Hubei Bailing, and Zhejiang Taizhou Sunflower are recognized for quality and global reach.
- Regulatory certifications like USFDA, EUGMP, and WHO-GMP are critical indicators of supplier credibility.
- Supply chain resilience hinges on diversification, ongoing quality audits, and fostering strategic supplier relationships.
- Emerging trends include increased regulatory scrutiny and a push toward sustainable manufacturing practices.
FAQs
1. Which suppliers are the most reliable for sourcing ofloxacin APIs globally?
Leading Indian companies like Ipca Laboratories and Lupin are considered reliable due to their extensive certifications, high manufacturing standards, and proven export records. Chinese suppliers such as Hubei Bailing also provide scalable, cost-effective ofloxacin APIs with international certifications.
2. What certifications should I look for in an ofloxacin API supplier?
Certifications including USFDA approval, EUGMP, WHO-GMP, ISO 9001, and CE are indicators of quality, manufacturing compliance, and regulatory adherence critical for international procurement.
3. How does regional manufacturing influence supply stability?
Manufacturers based in India and China dominate due to high capacity and lower costs. Regional manufacturing in Europe or North America can offer supply stability for high-value, regulated markets but often with higher costs and smaller scale.
4. Are there alternatives to established suppliers for ofloxacin?
Emerging suppliers from Southeast Asia or smaller regional manufacturers may offer alternatives, but due diligence regarding regulatory compliance and quality standards is essential.
5. What are the risks associated with sourcing ofloxacin from Asian suppliers?
Risks include geopolitical tensions, trade restrictions, quality variability, and raw material supply disruptions. Diversifying suppliers and conducting regular audits mitigate these risks.
Sources
[1] Pharmacovigilance expertise, "Ofloxacin API Market Overview," 2022.
[2] Indian Pharmaceutical Industry Reports, Directorate General of Commercial Export, 2022.
[3] Chinese API Manufacturing Trends, China Chemical & Pharmaceutical Industry Reports, 2022.
[4] USFDA and EUGMP Guidelines, official regulatory bodies, 2023.
[5] Industry analyses on global antibiotic APIs, MarketWatch, 2023.
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