Bulk Pharmaceutical API Sources for CYLERT

Bulk Pharmaceutical API Sources for CYLERT

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246706
NovoSeek		4723
ISpharm		I01-1045
ISpharm		I01-1046
ABI Chem		AC1L1IT8
AKos Consulting & Solutions		AKOS005065730

Bulk Active Pharmaceutical Ingredient (API) Sources for CYLERT

Last updated: July 29, 2025

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Introduction

CYLERT (phentermine hydrochloride) is a prescription medication primarily marketed for weight management and obesity treatment. As a sympathomimetic agent, phentermine acts as an appetite suppressant by stimulating the central nervous system, resulting in increased heart rate and blood pressure, alongside decreased appetite. The efficacy and safety of CYLERT depend heavily on the quality of its active pharmaceutical ingredient (API). Securing reliable bulk API sources is thus critical for manufacturers, distributors, and regulatory bodies involved in the production and quality assurance of this medication.

This report provides an in-depth analysis of current bulk API suppliers for CYLERT, emphasizing quality standards, sourcing considerations, regulatory compliance, and market dynamics.

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Regulatory Framework for API Supply

API sourcing for pharmaceuticals such as CYLERT requires adherence to stringent regulatory standards, primarily governed by agencies like the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Good Manufacturing Practice (GMP) guidelines. Suppliers must demonstrate compliance through certifications, validated manufacturing processes, and quality control documentation.

Particularly, for controlled substances like phentermine hydrochloride, additional oversight pertains, including licensing under the Controlled Substances Act (CSA) and stricter import/export controls.

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Global API Manufacturing Hubs

Significant API manufacturing hubs for phentermine hydrochloride are concentrated in regions with established GMP-compliant facilities:

• India: A dominant supplier with numerous GMP-certified facilities, offering cost advantages and high production capacity.
• China: Growing presence with competitive pricing, though regulatory transparency varies.
• European Union (EU): Limited local production but high-quality standards for imported APIs.
• United States: Some manufacturers produce APIs for domestic distribution, primarily under stringent FDA regulations.

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Leading API Suppliers for CYLERT (Phentermine Hydrochloride)

1. Indentified Major API Manufacturers

Manufacturer / Supplier	Location	Certification	Production Capacity	Notes
Hubei Topfond Pharmaceutical Co., Ltd.	China	cGMP, ISO 9001	High	Known for robust API production, including controlled substances.
Sun Pharmaceutical Industries Ltd.	India	WHO GMP, US DMF	Moderate to high	Commercially extensive, with multiple plant certifications.
Wuhan Hengan Chemical Co., Ltd.	China	cGMP	Moderate	Focus on controlled substances and specialty chemicals.
LGM Pharma	USA	FDA-approved, cGMP	High	Specializes in custom synthesis, including controlled substances.
Zhejiang Hisun Pharmaceutical Co., Ltd.	China	GMP	Large capacity	Provides APIs for various CNS drugs with quality focus.

2. Reputation and Compliance

• Suppliers such as Wuhan Hengan and LGM Pharma are known for transparent supply chains, detailed documentation, and adherence to international quality standards, critical for narcotic APIs like phentermine hydrochloride.
• Indian firms such as Sun Pharma benefit from cost-efficiency and GMP compliance but demand rigorous supplier audits when sourcing controlled substances.

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Quality and Regulatory Considerations

• Certification & Documentation: Suppliers should hold valid Drug Master Files (DMFs), and Certificates of Suitability (CEPs) where applicable, demonstrating compliance with pharmacopeial standards (USP, EP, BP).
• Purity Specifications: API should meet ≥99% purity standards, with thorough impurity profiling and stability testing.
• Controlled Substance Oversight: Due to phentermine’s status as a Schedule IV controlled substance in the US, APIs must be sourced from licensed entities with appropriate DEA registration for export/import.

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Market Dynamics and Supply Chain Trends

• Emerging Markets: India and China dominate API production, increasing their share in the global supply chain for controlled substances like phentermine.
• Regulatory Scrutiny: Tightening international regulations and import/export controls necessitate comprehensive due diligence, affecting API procurement strategies.
• Supply Security & Risk Management: Rapid COVID-19 disruptions highlighted the need for diversifying supply sources and maintaining strategic inventory buffers.

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Supply Chain Challenges

• Quality Variability: Variations between suppliers can impact API purity, affecting drug quality.
• Regulatory Compliance: Rapidly evolving regulations require ongoing supplier audits.
• Lead Times & Capacity Issues: Capacity constraints, especially amidst rising demand, can cause delays.

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Emerging Alternatives and Innovation

• Synthetic Process Improvements: Suppliers investing in greener, more efficient synthesis methods enhance sustainability and cost-effectiveness.
• Global Harmonization: International efforts aim to streamline regulatory requirements, simplifying API sourcing.

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Conclusion: Sourcing Strategy for CYLERT API

Secure sourcing of phentermine hydrochloride API requires balancing quality, compliance, cost, and supply stability. Key suppliers like LGM Pharma and Hubei Topfond offer validated, GMP-compliant products suitable for pharmaceutical manufacturing of CYLERT. Due diligence, regular audits, and adherence to regulatory frameworks are paramount, especially given the controlled nature of the API.

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Key Takeaways

• Regulatory compliance is non-negotiable; sourcing from GMP-certified, licensed manufacturers significantly mitigates legal and quality risks.
• India and China remain primary production hubs, with offerings at varying price points and levels of regulatory transparency.
• Due diligence and supplier audits are essential to ensure API purity, stability, and regulatory adherence.
• Supply chain resilience demands diversification and strategic inventory management.
• The evolving regulatory landscape necessitates continuous monitoring to adapt sourcing strategies accordingly.

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FAQs

Q1: What are the primary regulatory considerations when sourcing phentermine hydrochloride API for CYLERT?
Answer: Compliance with GMP standards, proper licensing, DEA registration for controlled substances, and documentation such as DMFs and Certificates of Analysis are essential. Regulatory adherence ensures product safety and legality.

Q2: Which countries are leading producers of phentermine hydrochloride API?
Answer: India and China dominate API production for phentermine hydrochloride, supported by numerous GMP-certified facilities.

Q3: How can I verify the quality of an API supplier for CYLERT?
Answer: By reviewing certifications (GMP, ISO), examining regulatory filings (DMFs, CEPs), conducting supplier audits, and requesting detailed Certificates of Analysis (CoA).

Q4: What are the risks associated with sourcing API from emerging markets?
Answer: Potential variability in quality, regulatory oversight disparities, logistical delays, and intellectual property concerns.

Q5: How does the controlled substance status of phentermine impact API sourcing?
Answer: It mandates strict licensing, DEA registration, and comprehensive documentation, increasing compliance complexity and regulatory oversight.

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References

[1] U.S. Food and Drug Administration. Controlled Substances Act Regulations.
[2] European Directorate for the Quality of Medicines & HealthCare. European Pharmacopoeia.
[3] LGM Pharma. API Sourcing and Quality Assurance Guidelines.
[4] Hubei Topfond Pharmaceutical Co., Ltd. Official Website.
[5] Sun Pharmaceutical Industries Ltd. Annual Report.