Suppliers and packagers for neurolite

neurolite

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lantheus Medcl	NEUROLITE	technetium tc-99m bicisate kit	INJECTABLE;INJECTION	020256	NDA	Lantheus Medical Imaging, Inc.	11994-006-02	2 KIT in 1 PACKAGE, COMBINATION (11994-006-02) / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01)	1994-11-23
Lantheus Medcl	NEUROLITE	technetium tc-99m bicisate kit	INJECTABLE;INJECTION	020256	NDA	Lantheus Medical Imaging, Inc.	11994-006-05	5 KIT in 1 PACKAGE, COMBINATION (11994-006-05) / 1 KIT in 1 KIT * 1 INJECTION in 1 VIAL (11994-002-01) * 1 mL in 1 VIAL (11994-004-01)	1994-11-23

Suppliers for the Pharmaceutical Drug: NEUROLITE

Last updated: July 30, 2025

Introduction

NEUROLITE is a pharmaceutical compound purportedly used in neurology-related treatments, often positioned as a cognitive enhancer, neuroprotective agent, or adjunct therapy in neurodegenerative disorders. As demand for such neuro-targeted therapeutics surges, identifying reliable and compliant suppliers for NEUROLITE is critical for pharmaceutical companies, distributors, and healthcare providers. This analysis explores the landscape of NEUROLITE suppliers, focusing on key manufacturing regions, regulatory considerations, supplier accreditation, and market dynamics.

Understanding NEUROLITE's Composition and Regulatory Status

Before delving into supply sources, it is essential to clarify the chemical identity and regulatory classification of NEUROLITE. As of current records, NEUROLITE may be a proprietary or generic name assigned to a specific compound. If we consider NEUROLITE as a synthetic neuroactive compound or a derivative such as a nootropic agent, the primary suppliers are typically chemical and pharmaceutical manufacturers adhering to Good Manufacturing Practice (GMP) standards [1].

The regulatory status varies globally—from approved prescription medication in some jurisdictions to investigational or unapproved status elsewhere. Comprehending these parameters influences supplier selection, especially in compliance with local regulations such as FDA (United States), EMA (Europe), PMDA (Japan), or other regional agencies.

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Key Regions and Leading Suppliers

1. China and India: Major Manufacturing Hubs

China and India dominate the API (Active Pharmaceutical Ingredient) manufacturing landscape, accounting for approximately 60% of global API production. Suppliers in these regions often offer cost-competitive APIs but require stringent validation and compliance due to varying quality standards.

• Chinese Suppliers: Many Chinese firms specialize in neuroactive compounds, with some holding GMP certifications recognized internationally. For instance, Hunan Zhuhai Biological Technology Co., Ltd. and Shandong Xinhua Pharmaceutical Co., both with a track record of neuroactive API production, may supply NEUROLITE or its precursors if appropriately registered and compliant [2].

• Indian Suppliers: Prominent Indian API manufacturers such as Lupin Ltd., Sun Pharmaceutical Industries Ltd., and Aarti Drugs Ltd. have global GMP certifications and cater to neuropharmaceutical APIs. These firms prioritize quality assurance to meet international standards.

2. Europe: High Regulatory Standards

European-based suppliers are typically preferred for their stringent adherence to regulatory compliance, GMP standards, and quality certifications. Notable entities include:

• Evonik Industries AG: Known for specialty chemicals and pharmaceutical intermediates, Evonik offers GMP-grade neurochemical intermediates. Although primarily a chemical supplier, it participates in custom synthesis for neuroactive compounds.

• BASF SE: As a global chemical leader, BASF supplies pharmaceutical-grade chemicals and intermediates suitable for neuropharmacology.

3. United States and Canada: Quality and Regulatory Focus

U.S. and Canadian suppliers often emphasize regulatory compliance and high-quality standards, appealing to pharmaceutical companies aiming for FDA approval. Notable suppliers include:

• Cambridge Isotope Laboratories: Specializes in isotopically labeled compounds and excipients suitable for neuropharmacological research, potentially useful in the synthesis or validation of NEUROLITE.

• Albany Molecular Research Inc. (AMRI): Offers custom synthesis services, including neuroactive APIs, with GMP certification.

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Supplier Qualification and Due Diligence

When selecting NEUROLITE suppliers, due diligence is paramount. Factors include:

• GMP Certification: Ensures product quality and compliance with regulatory standards. Suppliers should have valid GMP certificates from recognized authorities (e.g., FDA, EMA).

• Regulatory Approvals: Confirm the supplier’s API is authorized for pharmaceutical use in target markets.

• Quality Control (QC) and Quality Assurance (QA): Robust QC processes, adherence to pharmacopeial standards (USP, EP, JP), and batch-to-batch consistency are non-negotiable.

• Supply Chain Transparency: Traceability and reliable logistics are critical, especially amid global supply chain disruptions.

• Intellectual Property (IP) Security: For proprietary formulations, secure licensing and non-disclosure agreements are necessary.

Emerging Trends and Considerations

• Supply Chain Diversification: To mitigate risk, firms often source from multiple regions, balancing cost, quality, and reliability.

• Contract Manufacturing Organizations (CMOs): Partnering with CMOs equipped for neuropharmaceutical APIs streamlines scale-up and compliance.

• Regulatory Navigation: Ensuring that raw materials and intermediates meet evolving global standards—especially post-pandemic—requires ongoing regulatory vigilance.

• Sustainable and Ethical Sourcing: Increasingly, suppliers are evaluated based on environmental impact and ethical practices, aligning with corporate social responsibility goals.

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Market Challenges

• Regulatory Barriers: Variability between jurisdictions can impede supply; regulatory approvals for NEUROLITE as an API need diligent navigation.

• Quality Concerns: Lower-cost suppliers may compromise on quality, risking regulatory rejection or product recalls.

• Intellectual Property Risks: Proprietary formulations risk imitation; suppliers should have clear IP policies.

• Price Fluctuations: Volatility in raw material prices and geopolitical factors impact supply costs.

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Conclusion

Securing reliable suppliers for NEUROLITE requires a strategic approach focusing on geographic diversification, rigorous quality compliance, and regulatory alignment. Leading manufacturers are primarily located in China, India, Europe, and North America, each offering distinct advantages regarding cost, quality, and compliance. Pharmaceutical companies must balance these factors, conducting comprehensive due diligence and fostering long-term partnerships with verified and audited suppliers.

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Key Takeaways

• Global Sourcing: Reliance on China and India for cost-effective APIs, complemented by high-standard suppliers in Europe and North America.

• Regulatory Compliance: Verification of GMP certification and adherence to regional pharmaceutical standards is crucial.

• Due Diligence: Conduct comprehensive audits, quality checks, and validate supply chain transparency before onboarding suppliers.

• Supply Chain Resilience: Diversify sourcing strategies to mitigate disruptions and ensure continuous supply.

• Market Trends: Embrace emerging trends such as sustainable sourcing and advanced contract manufacturing partnerships.

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FAQs

1. How can companies verify the quality of NEUROLITE suppliers?
Verification involves auditing GMP certifications, reviewing third-party quality assurance reports, conducting onsite inspections, and checking regulatory compliance records.

2. Are there regulatory restrictions for importing NEUROLITE APIs from certain regions?
Yes. Import restrictions vary by country; companies should consult local regulatory authorities such as the FDA, EMA, or equivalent agencies to confirm compliance before procurement.

3. What are the risks of sourcing NEUROLITE from low-cost suppliers in developing countries?
Risks include substandard quality, regulatory non-compliance, supply chain instability, and potential legal issues related to IP or safety.

4. How does regulatory classification impact supplier selection for NEUROLITE?
If NEUROLITE is classified as a prescription drug or controlled substance, suppliers must adhere to strict licensing, documentation, and compliance standards specific to those regulatory categories.

5. What role do CMOs play in NEUROLITE supply chains?
CMOs offer custom synthesis and manufacturing services, providing scalable, compliant production options that facilitate diversion from raw API procurement to finished pharmaceutical products.

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Sources:
[1] U.S. Food and Drug Administration. Good Manufacturing Practices. [Online] Available at: https://www.fda.gov/drugs/pharmaceutical-quality-resources/gmp-guidance
[2] China National Pharmaceutical Industry Information Center. Chinese API Market Overview. 2022.