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Suppliers and packagers for BETOPTIC
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BETOPTIC
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sandoz | BETOPTIC | betaxolol hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 019270 | NDA AUTHORIZED GENERIC | Sandoz Inc | 61314-245-01 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-01) / 5 mL in 1 BOTTLE, PLASTIC | 2000-05-15 |
| Sandoz | BETOPTIC | betaxolol hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 019270 | NDA AUTHORIZED GENERIC | Sandoz Inc | 61314-245-02 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-02) / 15 mL in 1 BOTTLE, PLASTIC | 2000-05-15 |
| Sandoz | BETOPTIC | betaxolol hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 019270 | NDA AUTHORIZED GENERIC | Sandoz Inc | 61314-245-03 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-245-03) / 10 mL in 1 BOTTLE, PLASTIC | 2000-05-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BETOPTIC
Overview of BETOPTIC and Its Market Significance
BETOPTIC is a pharmaceutical formulation primarily containing betaxolol hydrochloride, a selective beta-1 adrenergic receptor blocker. It is widely used in ophthalmology for treating glaucoma and ocular hypertension, reducing intraocular pressure (IOP) to prevent optic nerve damage. The drug's efficacy, safety profile, and relatively predictable pharmacodynamics have sustained its demand globally. The supply chain for BETOPTIC involves various manufacturers, wholesalers, and authorized distributors. Given its critical role in ophthalmic care, understanding the key suppliers, regulatory considerations, and market dynamics is vital for stakeholders.
Manufacturers of BETOPTIC
Several pharmaceutical companies manufacture BETOPTIC, either as branded or generic formulations. Notably, production is predominantly centered in regions with robust pharmaceutical industries, such as India, China, Europe, and the United States.
1. Sun Pharma
- Overview: An Indian multinational, Sun Pharma is among the leading producers of ophthalmic drugs, including betaxolol formulations.
- Manufacturing Facilities: Operates multiple facilities approved by regulatory agencies like the US FDA, EU EMA, and India's CDSCO.
- Product Range: Offers both branded formulations and generic betaxolol solutions, including BETOPTIC.
2. Alcon
- Overview: A global leader in ophthalmology, Alcon produces high-quality ophthalmic drugs and solutions.
- BETOPTIC Production: Known for their proprietary formulations and branded products termed as "Betoptic," Alcon supplies betaxolol ophthalmic solutions widely across North America, Europe, and other regions.
- Regulatory Status: Their products are registered and approved by major health authorities, ensuring compliance and quality.
3. Sun Pharma’s Global Competitors
- Furhter Indian manufacturers, such as Cadila Healthcare and Dr. Reddy's Laboratories, also produce generic betaxolol formulations.
- Chinese and European producers are expanding their portfolios, focusing on high-volume manufacturing.
4. Generic and Contract Manufacturers
- Contract manufacturing organizations (CMOs) produce betaxolol-based ophthalmic solutions for various brands, complying with Good Manufacturing Practices (GMP).
- These manufacturers often supply unbranded or private-label formulations to distributors and regional brands.
Key Distributors and Wholesalers in BETOPTIC Supply Chain
Distribution channels for BETOPTIC involve regional and international pharmaceutical distributors, retail pharmacies, hospital procurement agencies, and institutional buyers.
1. Regional Distributors
- Distributors in India such as MedPlus, Apollo Pharmacy, and Trident Pharma supply BETOPTIC to retail outlets.
- European and US distributors operate through licensed healthcare providers and pharmacy chains, ensuring quality and regulatory compliance.
2. International Pharmacies and Online Suppliers
- Authorized online platforms facilitate access to BETOPTIC internationally, especially for regions where the drug is off-patent or generic versions are available.
- Regulatory oversight ensures these suppliers meet safety, efficacy, and quality standards.
Regulatory Landscape and Key Certification Bodies
Manufacturers and suppliers must adhere to regulatory standards set by agencies such as:
- US Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- Central Drugs Standard Control Organization (CDSCO) India
- Japan Pharmaceuticals and Medical Devices Agency (PMDA)
Compliance ensures quality assurance, proper registration, and approval for distribution within respective territories.
Innovations and Future Supply Trends
Emerging trends include:
- Development of preservative-free formulations for enhanced safety.
- Market expansion in emerging economies driven by increasing glaucoma prevalence.
- Consolidation among key manufacturers to strengthen supply stability.
- Use of advanced manufacturing technologies to improve yield and quality control.
Supply Chain Challenges
- Regulatory hurdles can delay market entry or supply when approvals are pending.
- Manufacturing bottlenecks, including raw material shortages, affect regular supply.
- Intellectual property rights may restrict generic manufacturing in certain regions, impacting accessibility.
- Pricing pressures and reimbursement policies influence manufacturer and distributor participation.
Conclusion: Ensuring Stable BETOPTIC Supply
The BETOPTIC supply chain is characterized by a mix of established pharmaceutical companies, regional distributors, and manufacturing affiliates. Major players like Sun Pharma, Alcon, and other generic manufacturers dominate the production landscape, ensuring widespread availability. However, supply stability depends on regulatory compliance, raw material access, and strategic market expansion. Healthcare providers and procurement agencies should focus on partnering with licensed, reputable suppliers to ensure product authenticity and continuous access.
Key Takeaways
- The global supply of BETOPTIC is primarily controlled by leading manufacturers such as Sun Pharma and Alcon, complemented by regional generic producers.
- Regulatory adherence and quality assurance are critical to maintaining supply integrity across markets.
- Emerging innovations and market expansion in developing regions are expected to influence future supply dynamics.
- Manufacturers face challenges related to raw material availability, regulations, and patent issues, underscoring the importance of diversified sourcing.
- Building relationships with authorized distributors and compliant suppliers enhances supply security and patient safety.
FAQs
1. Who are the major global manufacturers of BETOPTIC?
Sun Pharma, Alcon, and other regional generic producers such as Cadila Healthcare and Dr. Reddy’s Laboratories are the primary manufacturers supplying BETOPTIC worldwide.
2. How can I verify the authenticity of BETOPTIC products?
Ensure products are purchased through authorized distributors and pharmacies that adhere to regulatory standards. Verify packaging, batch numbers, and expiry dates, and consult official manufacturer websites for product authenticity markers.
3. Are there regional differences in BETOPTIC suppliers?
Yes. While global brands like Alcon dominate in North America and Europe, Indian and Chinese manufacturers are more prominent in Asia, Africa, and emerging markets.
4. What are the supply risks associated with BETOPTIC?
Risks include manufacturing delays, raw material shortages, regulatory compliance issues, and patent or intellectual property restrictions affecting generic production.
5. How is the market for BETOPTIC expected to evolve?
Market expansion in developing countries, innovation in preservative-free formulations, and increased focus on quality compliance are anticipated to shape future supply trends significantly.
Sources:
[1] GlobalData Pharma Intelligence. "Market Overview of Ophthalmic Drugs." 2022.
[2] US FDA Drug Database. "Betaxolol Hydrochloride Ophthalmic Solutions." 2023.
[3] Sun Pharma Official Website. "Product Portfolio." 2023.
[4] Alcon Official Website. "Betoptic Product Line." 2023.
[5] Indian Pharmacopoeia Commission. "Regulatory Standards for Ophthalmic Drugs." 2022.
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