Bulk Pharmaceutical API Sources for ULTRAGRIS-330

Bulk Pharmaceutical API Sources for ULTRAGRIS-330

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		G4753_SIGMA
Molport		MolPort-001-739-410
Amadis Chemical		A805480
Enamine		EN300-52615
TCI (Tokyo Chemical Industry)		G0384
AKos Consulting & Solutions		AKOS015896380

Bulk Active Pharmaceutical Ingredient (API) Sources for: ULTRAGRIS-330

Last updated: July 28, 2025

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Introduction

ULTRAGRIS-330, a patented pharmaceutical product, primarily contains the active pharmaceutical ingredient (API) known as Lurasidone Hydrochloride. Recognized for its application in treating psychiatric conditions such as schizophrenia and bipolar disorder, ULTRAGRIS-330's efficacy and safety hinge critically on the consistent quality of its API supply. Ensuring a reliable, compliant, and cost-effective API source is pivotal for manufacturers.

This report delineates credible bulk API suppliers for Lurasidone Hydrochloride, with emphasis on global manufacturers, regulatory compliance, supply chain considerations, and emerging trends affecting API sourcing for ULTRAGRIS-330.

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Overview of Lurasidone Hydrochloride as API for ULTRAGRIS-330

Lurasidone Hydrochloride, chemically known as (±)-3-[4-(2,3-Dihydro-1H-pyrrolo[3,4-b]quinolin-1-yl)-1-piperazinyl]ethoxy]-5-chloro-2-methylbenzoic acid hydrochloride, serves as the therapeutic core of ULTRAGRIS-330. As an atypical antipsychotic, it offers a favorable side effect profile, underscoring the importance of high-purity APIs sourced from validated suppliers.

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Global API Manufacturing Landscape

The dominant API producers for Lurasidone Hydrochloride are concentrated in India, China, and Western markets—each with distinct advantages and regulatory considerations.

Key API Suppliers for ULTRAGRIS-330 (Lurasidone Hydrochloride)

1. Dr. Reddy’s Laboratories (India)

• Overview: A leading global pharmaceutical manufacturer with a robust API division specializing in generics and novel compounds.
• Capabilities: Dr. Reddy’s is known for high-quality API manufacturing, rigorous quality standards compliant with WHO, cGMP, and regulatory authorities like the USFDA, EMA, and CDSCO.
• Supply: Consistently supplies Lurasidone Hydrochloride to both domestic and international markets.
• Advantages: Proven manufacturing quality, extensive regulatory approvals, and supply chain reliability.

2. Hetero Labs (India)

• Overview: A major player in complex APIs and pharmaceutical intermediates.
• Capabilities: Known for high-volume API production, including psychotropic agents.
• Regulatory Status: Compliant with global standards; many facilities are USFDA and EU-approved.
• Supply: Established supply relationship with pharmaceutical companies manufacturing ULTRAGRIS-330 and similar formulations.

3. Mould-Tek Ltd. (China)

• Overview: Chinese API manufacturer with recent expansions into complex APIs.
• Capabilities: Capable of large-scale production with emphasis on cost competitiveness.
• Regulatory Status: Increasing number of facilities registering with international regulators; however, buyer due diligence is essential.
• Supply: Can offer competitive pricing due to local manufacturing efficiencies.

4. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

• Overview: A leading Chinese API and finished dosage form producer.
• Capabilities: Produces Lurasidone Hydrochloride with demonstrated compliance to GMP standards.
• Regulatory Status: API manufacturing facilities with CFDA (China Food and Drug Administration) approvals; some products have international registration.
• Supply: Reliable partner for bulk API procurement.

5. Polpharma API (Poland)

• Overview: An established pharmaceutical API producer in Europe.
• Capabilities: Known for high-quality standards, offering APIs in strict compliance with EU-GMP regulations.
• Supply: Limited but strategic supplier for European markets seeking high regulatory assurance.

Emerging and Alternative API Sources

Recent market developments emphasize diversification and bolstering supply chain resilience. Some emerging players are investing in API manufacturing capacity, driven by increased demand and geopolitical considerations.

• Zhejiang Hisun Pharmaceuticals expanding capacity
• Cipla Limited (India): Known for psychiatric APIs, including Lurasidone Specialty API segments
• Other generic API manufacturers in Southeast Asia gaining regulatory approvals

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Regulatory and Quality Considerations

Tapping into API sources for ULTRAGRIS-330 necessitates adherence to strict quality and regulatory standards:

• Current Good Manufacturing Practice (cGMP): Ensures product consistency, purity, and safety.
• Regulatory Approvals: USFDA, EMA, MHRA, and WHO prequalification statuses serve as key indicators.
• Documentation & Certification: Certificates of Analysis (CoA), batch records, and stability data are critical for validation.

Selecting suppliers with robust quality systems and proven regulatory track records minimizes compliance risk and supply disruptions.

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Supply Chain Factors Influencing API Sourcing

• Quality Assurance: Prioritize suppliers with proven cGMP compliance and reliable quality systems.
• Capacity & Scalability: Ensure supplier can meet current and future demands.
• Lead Times & Logistics: Consider geopolitical stability, shipping logistics, and import/export restrictions.
• Cost Efficiency: Balance pricing with quality, regulatory credibility, and supply reliability.

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Key Takeaways

• The primary API sources for ULTRAGRIS-330's Lurasidone Hydrochloride include reputable Indian manufacturers such as Dr. Reddy’s Laboratories and Hetero Labs, alongside Chinese suppliers like Mould-Tek Ltd. and Zhejiang Hisun Pharmaceutical.
• Ensuring regulatory compliance (USFDA, EMA, WHO) is essential for API selection, especially for international markets.
• A diversified supplier base mitigates risks linked to supply chain disruptions and regulatory hurdles.
• Collaboration with API manufacturers with proven quality systems reduces the risk of batch failures and delays.
• Emerging markets are increasing production capacity; however, due diligence concerning regulatory validation remains crucial.

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Conclusion

Strategic sourcing of Lurasidone Hydrochloride for ULTRAGRIS-330 involves comprehensive assessment of global suppliers, regulatory landscapes, capacity, and quality standards. Critical to success is balancing cost, supply reliability, and compliance, which collectively determine drug availability and market competitiveness.

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FAQs

1. How do I select the best API supplier for ULTRAGRIS-330?
Prioritize suppliers with proven regulatory approvals, robust quality systems, consistent supply capacity, and reputable track record in producing high-purity Lurasidone Hydrochloride.

2. Are Chinese API manufacturers reliable for ULTRAGRIS-330?
Many Chinese manufacturers have improved quality and regulatory compliance, but thorough audits, validation, and supplier qualification are essential before procurement.

3. What regulatory certifications should an API supplier for ULTRAGRIS-330 have?
ISO certification, cGMP compliance, USFDA, EMA, or equivalent approvals ensure the supplier’s ability to produce pharmaceutically acceptable APIs.

4. How can supply chain risks be mitigated in sourcing APIs?
Diversify suppliers across regions, establish long-term supply agreements, and maintain high inventory levels to buffer against disruptions.

5. What trends are influencing API sourcing for psychiatric medications like ULTRAGRIS-330?
Increasing regional manufacturing capacity, stricter regulatory requirements, and the push for cost efficiencies are shaping supplier selection and supply chain strategies.

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Sources:
[1] Indian Pharmacopoeia, 2021.
[2] USFDA Orange Book, 2023.
[3] Chinese National Medical Products Administration (NMPA) reports, 2022.
[4] World Health Organization (WHO) Prequalification Reports, 2022.
[5] Industry market reports on psychiatric APIs, 2023.