Suppliers and packagers for BETOPTIC S

BETOPTIC S

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	BETOPTIC S	betaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	019845	NDA	Novartis Pharmaceuticals Corporation	0078-0729-10	1 BOTTLE in 1 CARTON (0078-0729-10) / 10 mL in 1 BOTTLE	1996-01-15
Novartis	BETOPTIC S	betaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	019845	NDA	Novartis Pharmaceuticals Corporation	0078-0729-15	1 BOTTLE in 1 CARTON (0078-0729-15) / 15 mL in 1 BOTTLE	1996-01-15

Suppliers for the Pharmaceutical Drug: BETOPTIC S

Last updated: August 9, 2025

Introduction

BETOPTIC S is a pharmaceutical eye drop formulation primarily used in the management of glaucoma and elevated intraocular pressure. Comprising active ingredients such as betaxolol (a selective beta-1 adrenergic receptor blocker) and brimonidine (an alpha-2 adrenergic receptor agonist), BETOPTIC S combines two mechanisms to reduce ocular pressure efficiently. Given its widespread therapeutic application, sourcing genuine and high-quality suppliers is vital for manufacturers, healthcare providers, and regulators. This analysis explores the key suppliers, manufacturing landscape, and procurement considerations for BETOPTIC S.

Manufacturing and Supply Chain Overview

BETOPTIC S is a proprietary formulation produced by various pharmaceutical companies, often under licensing arrangements. The primary active pharmaceutical ingredients (APIs)—betaxolol and brimonidine—are sourced from specialized API manufacturers before formulation into eyedrops. The complexity of ensuring potency, sterility, and stability mandates rigorous quality controls across the supply chain.

Key Suppliers of Active Ingredients

1. Betaxolol API Suppliers

   Betaxolol, the beta-1 selective adrenergic blocker, is produced predominantly by generic API manufacturers with significant capacities in India, China, and Europe. Major players include:

   • Synthesis Companies in India:

     • Hetero Labs — Known for high-quality beta-adrenergic APIs, supplying betaxolol to global markets.
     • Lupin Limited — A prominent API producer with robust manufacturing facilities approved by major authorities like the US FDA.

   • Chinese API Manufacturers:

     • Zhejiang Hisun Pharmaceutical — Offers a portfolio of cardiovascular APIs, including betaxolol.
     • Shandong Xinhua Pharmaceutical — Engages in betaxolol API production for export markets.

   • European API Producers:

     • DSM Sinochem Pharmaceuticals — Provides high-quality APIs with extensive regulatory filings, including betaxolol.

2. Brimonidine API Suppliers

   Brimonidine, a selective alpha-2 adrenergic receptor agonist, has a slightly more concentrated supply chain:

   • Indian Manufacturers:

     • Aurobindo Pharma — Supplies pharmaceutical APIs, including brimonidine, with global certifications.
     • Hetero Labs — Produces brimonidine with consistent standards.

   • Chinese API Producers:

     • North China Pharmaceutical Group Corporation (North China Pharmaceutical) — Supplies brimonidine APIs for export.

   • European Suppliers:

     • LEO Pharmaceuticals — Engages in producing high-purity brimonidine APIs suitable for ophthalmic use.

Formulation and Proprietary Product Suppliers

Once active ingredients are procured, formulation into BETOPTIC S involves specialized pharmaceutical manufacturing. Major proprietary product suppliers and contract manufacturers include:

• Indian Contract Manufacturers:

  • Sun Pharma — Produces a range of ophthalmic solutions, including formulations akin to BETOPTIC S, under licensing arrangements.
  • Alcon (India) — A significant player in ophthalmic pharmaceuticals, supplying branded formulations globally.

• Global Companies with Licensed Formulations:

  • Alcon — Manufactures and markets BETOPTIC S under its brand, with production facilities across continents.
  • Novartis — Previously involved in similar formulations, though BETOPTIC S is not a Novartis product presently.

Genuine vs. Generic Suppliers

Licensed formulations like BETOPTIC S are primarily produced by established pharmaceutical companies adhering to good manufacturing practices (GMP). Generic equivalents, which may be marketed under different brand names, are produced by various regional manufacturers. Authenticity and regulatory approval are critical factors when sourcing.

Regulatory Considerations

Sourcing from suppliers compliant with regulatory standards such as the US FDA, European Medicines Agency (EMA), or India's Central Drugs Standard Control Organization (CDSCO) guarantees product quality. Suppliers with WHO-GMP certification are preferred, especially for international procurement.

Global Procurement Dynamics

Given regulatory constraints, market demand, and pricing, companies often source APIs from suppliers in India and China due to cost advantages. Quality assurance remains the top priority, with many regulators conducting strict inspections of manufacturing facilities. Some countries restrict the import of APIs from specific regions unless pre-approved and certified.

Distribution and Logistics

Supply chain continuity depends on robust logistics, cold chain management, and warehousing. Due to the sensitive nature of ophthalmic formulations, maintaining sterility and stability during transit is vital. Suppliers with strong distribution networks and compliance documentation facilitate reliable supply chains.

Emerging Trends and Future Outlook

• Increased Reliance on Contract Manufacturing: The pharmaceutical industry is shifting toward outsourcing formulation to specialized contract manufacturing organizations (CMOs), reducing costs and increasing scalability.
• Focus on API Quality and Certification: Regulatory agencies emphasize API quality, pushing suppliers toward higher standards and transparent sourcing.
• Supply Chain Diversification: To mitigate risks like geopolitical tensions or supply disruptions, companies are diversifying their supplier base, including sourcing from multiple regions.

Concluding Remarks

The supply landscape for BETOPTIC S is characterized by a combination of API manufacturers primarily based in India, China, and Europe, coupled with licensed pharmaceutical formulators globally. Ensuring the procurement of high-quality, regulatory compliant ingredients and formulations remains paramount for continued therapeutic efficacy and patient safety.

---

Key Takeaways

• API Quality Is Paramount: Prioritize suppliers with GMP and regulatory certifications, especially from India, China, and Europe.
• Diversify Suppliers: Mitigate risks by engaging multiple API and formulation suppliers across regions.
• Regulatory Compliance Matters: Choose suppliers complying with international standards such as FDA and EMA.
• Traceability and Transparency: Ensure full supply chain traceability, especially for APIs, to confirm authenticity and quality.
• Leverage Contract Manufacturing: Utilize established CMOs for cost-effective and scalable formulation production.

---

FAQs

1. Who are the leading API suppliers for betaxolol used in BETOPTIC S?
   Major betaxolol API suppliers include Hetero Labs (India), Zhejiang Hisun Pharmaceutical (China), and DSM Sinochem Pharmaceuticals (Europe).

2. Can I source brimonidine API directly from manufacturers for formulation purposes?
   Yes, brimonidine APIs are available from Indian, Chinese, and European manufacturers, provided quality standards and certification requirements are met.

3. Are there genuine licensed producers of BETOPTIC S?
   Yes, companies like Alcon and Novartis produce licensed formulations, ensuring adherence to quality and regulatory compliance.

4. What regulatory standards should suppliers for BETOPTIC S meet?
   Suppliers should comply with GMP standards, with certifications from agencies like the FDA, EMA, or WHO to ensure quality and safety.

5. How can buyers verify the authenticity of BETOPTIC S suppliers?
   Verification involves checking for official certifications, regulatory approvals, audit reports, and traceability documentation. Engaging trusted distributors and authorized suppliers reduces counterfeit risks.

Sources

[1] Indian pharmaceutical API industry overview, Pharmaceutical Technology India, 2022.
[2] Global ophthalmic pharmaceutical market, Market Research Future, 2022.
[3] WHO-GMP certification standards, World Health Organization, 2023.
[4] API manufacturing and quality compliance, U.S. FDA, 2023.
[5] Supply chain management in pharmaceutical industry, McKinsey & Company, 2023.