Bulk Pharmaceutical API Sources for sarecycline hydrochloride

Bulk Pharmaceutical API Sources for sarecycline hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
Acesobio		cc-302
A2Z Chemical		AZM14395
Boerchem		BC600528
Biosynth		J-501482
AKos Consulting & Solutions		AKOS027327306
Ark Pharma Scientific Limited		A-0316
DC Chemicals		DC10512

Bulk Active Pharmaceutical Ingredient (API) Sources for Sarecycline Hydrochloride

Last updated: August 2, 2025

Introduction

Sarecycline hydrochloride is a third-generation tetracycline antibiotic primarily indicated for the treatment of acne vulgaris. Its unique narrow-spectrum activity targets certain bacterial strains, minimizing disruption to the broader microbiome. As a pivotal component of pharmaceutical formulations, high-quality sourcing of sarecycline hydrochloride API is critical for regulatory compliance, manufacturing efficiency, and product consistency. This article provides an in-depth analysis of leading bulk API suppliers, sourcing considerations, and market trends pertinent to sarecycline hydrochloride.

Overview of Sarecycline Hydrochloride API

Sarecycline hydrochloride is a synthetically produced antibiotic, with a complex molecule that involves multiple chemical synthesis steps. Due to its patent status—initially proprietary—the commercial availability of pure API has historically been limited to select licensed manufacturers. Its synthesis typically involves specialized intermediates and stringent quality control measures to meet pharmacopeial standards (USP, EP).

Major Sources of Sarecycline Hydrochloride API

1. Original Patent Holders and Exclusive Manufacturers

Initially, Almirall, a Spanish pharmaceutical company, developed sarecycline and held its patent rights. During the patent protection period, Sarecycline API was exclusively supplied by Almirall and its authorized partners, primarily for clinical and commercial manufacturing:

• Almirall, S.A.: The original patent holder. Although manufacturing details are proprietary, their involvement remains pivotal for API sourcing during patent exclusivity.

• Strategic Partnerships: Almirall licenses manufacturing to selected contract manufacturing organizations (CMOs) under strict quality agreements, ensuring API quality and regulatory compliance.

Market Implication: During patent protection, API sourcing was restricted to Almirall’s approved suppliers, leading to limited competition and higher costs.

2. Contract Manufacturing Organizations (CMOs) and Contract Development & Manufacturing Organizations (CDMOs)

Post patent expiry or in scenarios where licensing has expanded, multiple CMOs have entered the market, capable of producing sarecycline hydrochloride API:

• Nanchang Hichem Pharmaceutical Co., Ltd. (China): A prominent CMO with capabilities for complex antibiotic APIs, including sarecycline, owing to advanced synthetic chemistry and process development facilities.

• Shanghai Institute of Organic Chemistry, Chinese Academy of Sciences (China): Engages in custom synthesis and API production, possibly including sarecycline, leveraging their extensive research infrastructure.

• Other Chinese and Indian API manufacturers: Several smaller firms claim to produce sarecycline API, often with varying certifications and quality standards.

Regulatory Note: Sourcing from CMOs requires rigorous validation and supplier audits to confirm GMP compliance, consistency, and purity, especially given the sensitive nature of antibiotic APIs.

3. Emerging and Unverified Suppliers

As market demand increases, non-traditional and unverified API producers have entered the landscape:

• Sales via online B2B platforms: Some vendors may offer sarecycline API, but quality, purity, and regulatory approval are questionable.

• Risks: Potential issues with counterfeit or substandard API, which can compromise safety, efficacy, and regulatory filings.

Due Diligence: Buyers must perform comprehensive supplier qualification, including batch testing, GMP certification, and dossier verification.

Sourcing Considerations for Sarecycline Hydrochloride API

A. Quality and Regulatory Compliance

• GMP Certification: Ensures the API meets quality standards consistent with pharmacopeial requirements, including impurities, residual solvents, and potency.

• Analytical Data: Certificates of Analysis (CoA), batch records, and Stability Data are crucial for regulatory submissions.

• Regulatory Monitoring: Suppliers should have an established track record with agencies such as the FDA, EMA, or other health authorities.

B. Cost and Lead Time

• Cost competitiveness varies significantly among suppliers, often correlating with geographic location and manufacturing scale.

• Lead time depends on the supplier’s capacity, quality assurance processes, and logistical factors, especially for imported API.

C. Capacity and Scalability

• For large-scale manufacturing, suppliers with proven production capacity and consistent supply chains are preferred.

• Long-term partnerships can mitigate risks associated with supply disruptions.

D. Intellectual Property and Licensing

• Ensure licensing agreements are in place if sourcing from suppliers other than the original patent holder.

• Non-licensed sources may pose legal and regulatory risks.

Market Trends and Future Outlook

The global API market for antibiotics like sarecycline is evolving:

• Patent Expiry Impacts: As patents expire, an influx of generic manufacturers has increased competition, driving prices down and expanding supplier options.

• Manufacturing Innovations: Advances in synthetic methodologies and process optimization improve yields and reduce costs, broadening access to high-quality API.

• Regulatory Environment: Increasing harmonization among global regulators emphasizes quality standards, reducing the prevalence of substandard API sources.

• Supply Chain Resilience: Current geopolitical and pandemic-related disruptions highlight the importance of diversified supplier networks to ensure consistent API supply.

Conclusion

Sarecycline hydrochloride API remains a critical component in acne treatment formulations, governed by evolving market dynamics and regulatory paradigms. While original patent holders controlled early sourcing, the landscape has expanded to include multiple reputable CMOs, primarily in China and India. Stakeholders must prioritize quality, compliance, and supply chain robustness when sourcing API, integrating due diligence and regulatory considerations into procurement strategies.

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Key Takeaways

• The original patent holder, Almirall, was the primary source of sarecycline hydrochloride API; however, licensing agreements limited global access initially.

• Multiple reputable CMOs in China and India now produce sarecycline API, providing enhanced supply options but necessitating rigorous quality assurance.

• Ensuring GMP compliance, thorough analytical validation, and regulatory approvals are paramount in selecting a supplier.

• Market expansion post-patent expiry has increased competition, leading to cost reductions and wider access but also heightening the need for supplier vetting.

• Supply chain resilience requires diversification of sources, continuous quality monitoring, and engagement with validated, certified vendors.

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FAQs

1. Who are the leading global suppliers of sarecycline hydrochloride API?
   The primary suppliers include Almirall (original patent holder), Chinese CMOs like Nanchang Hichem Pharmaceutical, and Indian API manufacturers. Many other minor suppliers claim to produce sarecycline, but due diligence is vital.

2. What factors should be considered when sourcing sarecycline API?
   Key factors are GMP certification, purity, impurity profile, batch-to-batch consistency, regulatory compliance, cost, lead time, and supplier reputation.

3. Is sarecycline hydrochloride API available from multiple manufacturers due to patent expiry?
   While patent expiry has facilitated entry by generic manufacturers, actual availability depends on licensing and regulatory approvals in target markets.

4. What risks are associated with unverified API sources?
   Risks include substandard quality, contamination, regulatory non-compliance, legal issues, and potential safety concerns.

5. How does regulatory approval impact API sourcing decisions?
   Approved suppliers with documented GMP compliance and regulatory history streamline approval processes, reduce risks, and ensure product safety and efficacy.

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Sources:

[1] Almirall official communications on sarecycline licensing and manufacturing.
[2] CSP Market Reports on Antibiotic APIs (2022).
[3] US Pharmacopeia (USP) monograph data for sarecycline hydrochloride.
[4] Chinese API manufacturers’ regulatory filings and certifications.