Bulk Pharmaceutical API Sources for levobetaxolol hydrochloride

Bulk Pharmaceutical API Sources for levobetaxolol hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
ABI Chem		AC1L1TNZ
ABI Chem		AC1Q3DQ3
AK Scientific, Inc. (AKSCI)		V1820
Chembase.cn		179714
MolPort		MolPort-027-720-680
BOC Sciences		116209-55-3
MedChemexpress MCE		HY-B0381B

Bulk Active Pharmaceutical Ingredient (API) Sources for: Levobetaxolol Hydrochloride

Last updated: August 4, 2025

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Introduction

Levobetaxolol hydrochloride is a selective beta-1 adrenergic receptor blocker primarily used in ophthalmology to lower intraocular pressure in conditions such as glaucoma and ocular hypertension. As a chiral molecule, it is the S-enantiomer of betaxolol, offering potentially improved efficacy and reduced side effects. Its commercial manufacturing relies on high-quality bulk API sources to ensure drug safety, efficacy, and regulatory compliance. This analysis explores the key API suppliers for levobetaxolol hydrochloride, including manufacturing capabilities, sourcing trends, and considerations for procurement.

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Overview of Levobetaxolol Hydrochloride

Levobetaxolol hydrochloride is chemically known as (S)-α-[4-(2-Hydroxy-3-isopropylamino-propoxy)phenyl]acetamide hydrochloride. It is a stereospecific beta-1 selective blocker with the molecular formula C_15H_24ClN_2O_3. Its production hinges on chiral synthesis or resolution techniques to obtain enantiomeric purity, critical for its biological activity and regulatory approval.

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Global API Manufacturing Landscape

The API market for levobetaxolol hydrochloride is relatively niche, driven largely by major pharmaceutical companies specializing in ophthalmic drugs and custom API manufacturers with expertise in chiral synthesis. The industry is characterized by high regulatory standards, necessitating quality certifications such as cGMP (current Good Manufacturing Practice), and adherence to stringent quality control measures.

In recent years, there has been a trend towards sourcing from low-cost manufacturing hubs in India and China, with many producers offering APIs aligned with international pharmacopeial standards (USP, EP, or JP). However, due to the specificity and potency of ophthalmic APIs, buyers prioritize quality and compliance over cost savings.

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Top API Suppliers for Levobetaxolol Hydrochloride

1. Major Pharmaceutical Ingredient Suppliers in India

• Shilpa Pharmacy Ltd.

  • Capabilities: Specializes in beta-blockers and ophthalmic APIs, including custom synthesis of chiral compounds.
  • Quality Standards: cGMP-certified, ISO 9001, and USFDA-approved facilities.
  • Market Position: Known for consistent quality, competitive pricing, and reliable supply chains.

• Aarti Drugs Ltd.

  • Capabilities: Produces a range of beta-adrenergic blockers with experience in chiral API synthesis.
  • Quality Standards: Adheres to WHO-GMP, with extensive regulatory approval in multiple markets.

• Strides Pharma Science

  • Capabilities: Offers both finished APIs and intermediates, including enantiomerically pure beta-blockers.
  • Quality Standards: cGMP and USFDA compliant manufacturing processes.

2. Chinese API Manufacturers

• Qingdao Greenhope Pharmaceuticals

  • Capabilities: Specializes in chiral pharmaceutical APIs, leveraging proprietary asymmetric synthesis techniques.
  • Quality Standards: Good manufacturing practices and CAPA systems aligned with international standards.

• Shanghai Anyu Pharmaceutical Co., Ltd.

  • Capabilities: Manufactures various ophthalmic APIs with focus on chiral purity.
  • Regulatory: Capable of meeting international quality benchmarks with proper certifications.

3. European and North American API Suppliers

While less prevalent due to higher production costs, select suppliers maintain manufacturing facilities compliant with EU and US regulations.

• BASF Pharma Solutions

  • Capabilities: Offers tailor-made APIs including chiral compounds for ophthalmic indications.
  • Quality: Known for high purity standards and extensive quality assurance.

• MilliporeSigma (Merck KGaA)

  • Capabilities: Provides APIs and custom synthesis services, with a focus on regulatory compliance and safety.

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Sourcing Considerations

Regulatory Compliance: Ensuring API suppliers are compliant with relevant pharmacopeial standards is paramount. Certifications such as cGMP, ISO, USFDA approval, and EU-GMP are critical indicators of quality assurance.

Chirality and Purity: Levobetaxolol’s efficacy depends on enantiomeric purity. Suppliers must demonstrate rigorous chiral resolution or asymmetric synthesis processes, with provided analytical data (e.g., chiral HPLC).

Supply Reliability: The niche nature of levobetaxolol API demands suppliers with robust manufacturing capacity and proven supply chain security to prevent shortages.

Cost Efficiency: Balancing cost with quality is essential. Indian and Chinese suppliers offer competitive pricing, whereas Western suppliers tend to command premium prices aligned with higher certifications.

Intellectual Property and Licensing: Buyers should verify licensing agreements, especially when sourcing from third-party manufacturers, to avoid IP infringement.

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Emerging Trends and Future Outlook

The landscape for levobetaxolol hydrochloride API sourcing is evolving amid regulatory pressures to ensure API quality and traceability. Contract manufacturing organizations (CMOs) with expertise in stereoselective synthesis are increasingly favored. Additionally, advances in asymmetric catalysis and biocatalysis are expanding options for producing high-purity APIs.

Furthermore, supply chain diversification is gaining importance due to geopolitical and pandemic-related disruptions. Companies sourcing from multiple regions mitigate risks and secure continuous supply.

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Conclusion

Sourcing levobetaxolol hydrochloride API involves evaluating supplier capabilities in chiral synthesis, regulatory compliance, and supply reliability. Indian and Chinese manufacturers dominate the market, offering competitive quality and cost solutions aligned with international standards. European and North American suppliers, though limited, provide high-certainty options for clients prioritizing premium quality.

Successful procurement strategies depend on rigorous quality assessments, reputation verification, and aligning supplier capabilities with regulatory and logistical requirements. Partnerships with reputable API manufacturers underpin the consistent supply of this niche ophthalmic drug, ensuring patient safety and therapeutic efficacy.

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Key Takeaways

• The primary API sources for levobetaxolol hydrochloride are based in India, China, with select high-standard suppliers in Europe and North America.
• Ensuring chiral purity and regulatory compliance is crucial when selecting API suppliers due to the enantioselective nature of levobetaxolol.
• Cost-effective sourcing from emerging markets is feasible but must be balanced with stringent quality assurance measures.
• Continuous monitoring of supplier certifications and manufacturing processes is essential to mitigate supply risks.
• The trend toward asymmetric synthesis and biocatalytic methods enhances API quality and supply security.

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FAQs

1. What are the primary countries manufacturing levobetaxolol hydrochloride API?
India and China are the leading producers of levobetaxolol hydrochloride API, with a smaller presence in Europe and North America, mainly focusing on high-standard suppliers.

2. How important is enantiomeric purity in sourcing levobetaxolol API?
It is critical. The therapeutic activity resides mainly in the S-enantiomer, necessitating suppliers to demonstrate rigorous chiral purity through validated analytical methods.

3. What certifications should API suppliers for levobetaxolol have?
Ideal certifications include cGMP, ISO 9001, EU-GMP, and USFDA approvals, ensuring adherence to internationally recognized quality standards.

4. Are there specific challenges associated with sourcing chiral APIs like levobetaxolol?
Yes, the synthesis and resolution of chiral compounds are complex, often requiring specialized manufacturing processes, which can impact cost and supply reliability.

5. What trends are shaping the future of API sourcing for ophthalmic drugs?
Advances in asymmetric catalysis, increased emphasis on supply chain diversification, and regulatory convergence are shaping the procurement landscape of ophthalmic APIs like levobetaxolol.

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Sources:

1. [1] "API Market Insights," Pharmaceutical Technology Magazine, 2022.
2. [2] "Chiral API Manufacturing," International Journal of Pharmaceutical Quality Assurance, 2021.
3. [3] "Global API Supply Chain Dynamics," World Health Organization, 2020.
4. [4] "Regulatory Standards for Ophthalmic APIs," U.S. FDA Guidance Document, 2021.
5. [5] "Emerging Trends in API Synthesis," Chemical & Engineering News, 2022.