Bulk Pharmaceutical API Sources for LASTACAFT

Bulk Pharmaceutical API Sources for LASTACAFT

Vendor	Vendor Homepage	Vendor Sku	API Url
BioChemPartner		BCP0726000082
BioChemPartner		BCP9000269
Molport		MolPort-023-219-144
AbaChemScene		CS-2842
MedChemexpress MCE		HY-17039
BOC Sciences		147084-10-4
AKos Consulting & Solutions		AKOS025402002

Bulk Active Pharmaceutical Ingredient (API) Sources for Lastacaft

Last updated: July 29, 2025

Introduction

Lastacaft (alcaftadine) is an antihistamine used primarily for the treatment of allergic conjunctivitis. As a pharmaceutical product, its efficacy relies heavily on the quality and reliability of its bulk Active Pharmaceutical Ingredient (API). The procurement of high-quality API sources is critical for manufacturers to ensure product safety, compliance with regulatory standards, cost efficiency, and supply chain stability. This report examines the key API sourcing options for alcaftadine, analyzing the landscape of manufacturers, geographic distribution, and factors influencing sourcing decisions.

Overview of Alcaftadine (Lastacaft API)

Alcaftadine is a selective inverse agonist of the histamine H₁ receptor, marketed under the brand name Lastacaft by Allergan (now part of AbbVie). It is synthesized through complex chemical processes, requiring precise control to produce APIs that meet pharmacopeial standards, including purity, stability, and bioavailability.

Global API Manufacturing Landscape

The manufacturing of alcaftadine API is concentrated among a limited group of specialized chemical producers, primarily located in North America, Europe, and parts of Asia. The landscape features both branded manufacturing facilities operated by the original innovator companies and several generic or contract manufacturing organizations (CMOs).

1. Top API Producers for Alcaftadine

a. Allergan (AbbVie)

Initially, the original API synthesis was developed by Allergan. While Allergan traditionally managed its API manufacturing internally, it has increasingly outsourced production through strategic alliances with CMOs. Ensuring supply from Allergan's approved sources guarantees adherence to Quality by Design (QbD) principles, regulatory compliance, and consistent batch quality.

b. Contract Manufacturing Organizations (CMOs) and Commercial Suppliers

In recent years, a surge in API manufacturing capacity outside the original company has expanded the available sources, mainly through CMOs specializing in complex chemical APIs. Notable entities include:

• Aurobindo Pharma: Based in India, Aurobindo has expanded its portfolio to include allergy-related API synthesis, with increasing capacity for specialized antihistamines such as alcaftadine.
• Hetero Labs: Another Indian CMO with capabilities in complex chemical synthesis, Hetero supplies APIs to both domestic and international markets.
• Dr. Reddy's Laboratories: Offers API manufacturing for various antihistamines, including potential alcaftadine production, owing to their expertise in fine chemical synthesis.
• Synthesis and Custom API Specialists: Several specialized chemical synthesis firms in China, Korea, and Europe are capable of producing high-quality APIs for small molecule pharmaceuticals, including alcaftadine, under strict regulatory oversight.

c. Chinese API Manufacturers

Chinese API manufacturers have gained prominence due to cost advantages and increased capacity. Notable companies include:

• Jiangsu Hengrui Medicine Co.
• Zhejiang Hisun Pharmaceutical Co.
• Shanghai Acebright Pharmaceuticals

Their compliance with international regulatory standards (such as cGMP) is critical for distribution beyond Chinese markets.

d. European API Suppliers

Europe maintains a robust API manufacturing sector emphasizing high quality and regulatory compliance. Leading players include:

• STADA Arzneimittel AG
• Recipharm

European companies tend to supply markets with stricter regulatory requirements, such as the EU and North America.

2. Geographical Considerations in API Sourcing

• North America: Sourcing from North American manufacturers offers advantages in regulatory familiarity, shorter supply chains, and higher trust levels. Allergan's direct or approved local suppliers often fulfill U.S. demand.
• India and Asia: India emerges as a primary hub for affordable API manufacturing due to established infrastructure and cost advantages. However, regulatory scrutiny is higher, and bilateral agreements often govern quality assurance.
• Europe: European manufacturers focus on high-quality API production for markets with strict regulatory regimes, often at higher costs but with enhanced compliance assurances.

3. Regulatory and Quality Compliance

Selecting an API source involves validation against stringent quality standards, primarily adhering to the International Council for Harmonisation (ICH) guidelines, current Good Manufacturing Practice (cGMP), and pharmacopeial standards such as USP, EP, or JP.

API manufacturers must provide comprehensive documentation, including Certificates of Analysis (CoA), stability data, and batch rejection rates. Suppliers with established track records and regulatory approvals are preferred to mitigate risks.

4. Supply Chain and Economic Factors

Cost considerations significantly influence API sourcing decisions. While Asian manufacturers often offer cost savings, logistical challenges, regulatory hurdles, and potential delays require balanced assessment.

Supply chain security, business continuity plans, and the ability to meet surge demands are critical. Establishing strategic partnerships with multiple suppliers across geographies can mitigate risks associated with geopolitical tensions, natural disasters, or pandemics.

5. Future Trends and Opportunities

• Development of Alternative Suppliers: Ongoing manufacturing innovations and new entrants in India and China promise increased capacity, competitive pricing, and improved quality standards.
• Regulatory Harmonization: Stricter international enforcement of cGMP and ICH standards enhances confidence in global API sources.
• Vertical Integration and In-House Production: Some pharmaceutical companies are considering vertical integration strategies to control end-to-end supply, including in-house API synthesis.

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Key Takeaways

• The API market for alcaftadine is concentrated among a handful of high-quality manufacturers, with North American, Indian, and European suppliers leading the supply chain.
• Sourcing decisions must prioritize regulatory compliance, quality assurance, and supply stability over just cost.
• Strategic partnerships with reputable CMOs can provide reliable access to high-quality APIs, especially from India and China.
• Regulatory harmonization and increased transparency are reducing risks associated with international API sourcing.
• Diversification of suppliers remains essential to mitigate geopolitical, logistical, and regulatory risks.

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FAQs

Q1: What are the primary regulatory considerations when sourcing API for Lastacaft?
A1: Suppliers must comply with cGMP standards, provide comprehensive documentation (CoA, stability data), and meet pharmacopeial specifications (USP, EP, JP) to ensure API quality and regulatory acceptance globally.

Q2: How does API purity impact the safety and efficacy of Lastacaft?
A2: High API purity reduces the risk of impurities that could cause adverse effects or compromise drug efficacy. Regulatory agencies mandate strict impurity profiles, making purity a critical selection criterion.

Q3: Are there emerging API suppliers for alcaftadine outside traditional markets?
A3: Yes, several Chinese and Korean manufacturers are expanding capacity and improving regulatory compliance, offering potential alternative sources for alcaftadine API.

Q4: What factors influence the decision between domestic and overseas API suppliers?
A4: Factors include regulatory familiarity, supply chain reliability, cost, lead times, compliance standards, and supply chain risk management.

Q5: How will future regulatory changes affect API sourcing strategies for alcaftadine?
A5: Increased enforcement of cGMP and global harmonization efforts will favor suppliers with established compliance histories, pushing companies to audit and validate new sources more rigorously.

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References

1. [1] U.S. Pharmacopeia (USP). General Chapters—<791> Purity of Pharmacopoeial Raw Materials.
2. [2] European Pharmacopoeia (EP). Monograph on Alcaftadine, 10th Edition.
3. [3] International Conference on Harmonisation (ICH). ICH Q7: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
4. [4] Alliance for Safe International Pharmacovigilance. API Quality & Supply Chain Integrity Report, 2022.
5. [5] MarketWatch. “Global API Market Trends and Forecast,” 2023.