Bulk Pharmaceutical API Sources for DRIZALMA SPRINKLE

Bulk Pharmaceutical API Sources for DRIZALMA SPRINKLE

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246523
NIH Clinical Collection		SAM001247059
NovoSeek		60834
NovoSeek		60835
MolPort		MolPort-003-666-661
MolPort		MolPort-003-847-038

Bulk Active Pharmaceutical Ingredient (API) Sources for: DRIZALMA SPRINKLE

Last updated: July 29, 2025

Introduction

The integrity of pharmaceutical manufacturing heavily relies on the quality, reliability, and supply chain stability of Active Pharmaceutical Ingredients (APIs). For medications like Drizalma Sprinkle—an oral dispersible form containing duloxetine hydrochloride used predominantly for major depressive disorder and generalized anxiety disorder—it is crucial to source high-quality APIs from established suppliers. This article explores the primary bulk API sources for duloxetine hydrochloride, the considerations influencing supplier selection, regulatory compliance, and the current landscape underpinning API procurement for this specialized formulation.

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Overview of Drizalma Sprinkle and Its API: Duloxetine Hydrochloride

Drizalma Sprinkle is a patented formulation of duloxetine hydrochloride, marketed by Sun Pharma, designed for pediatric and adult populations requiring flexible dosing through its dispersible form. The API, duloxetine hydrochloride, is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), classified as a critical compound necessitating stringent quality standards.

The API’s sourcing influences drug efficacy, safety profiles, regulatory approval, and manufacturing consistency. Given its widespread use, multiple global suppliers provide duloxetine hydrochloride that meet the pharmaceutical industry’s stringent specifications.

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Global API Manufacturers of Duloxetine Hydrochloride

1. Major Contract Manufacturing Organizations (CMOs)

Several prominent contract and dedicated API manufacturers serve as bulk API sources for duloxetine hydrochloride, primarily from regions with well-established pharmaceutical industries such as India, China, and Europe.

• Sun Pharmaceutical Industries Ltd. (India)

  As the originator of Drizalma Sprinkle, Sun Pharma produces the API either in-house or through vetted third-party suppliers. The company maintains a vertically integrated supply chain ensuring API quality aligned with Good Manufacturing Practices (GMP).

• Linhai Hengtai Pharmaceutical Co., Ltd. (China)

  Known for manufacturing active pharmaceutical ingredients, Hengtai supplies duloxetine hydrochloride for generic markets. Their facilities are GMP-certified, boasting comprehensive quality control systems.

• Hainan Eltopia Pharmaceutical Co., Ltd. (China)

  This manufacturer specializes in producing SNRI APIs, including duloxetine hydrochloride. Their facilities are compliant with international quality standards, with exports certified under various regulatory regimes like the Chinese GMP, EDQM, and others.

• Hetero Labs Ltd. (India)

  Hetero has a robust API manufacturing division producing duloxetine hydrochloride for global clients. Their production adheres to stringent regulatory norms, and API is supplied to both generic and branded drug manufacturers.

• Mingxin Pharmaceutical (China)

  An established API producer specializing in CNS-active compounds, including duloxetine hydrochloride. Mingxin's API products are routinely inspected and certified to meet international standards.

2. Leading API Exporters and Suppliers in India & China

India and China remain the dominant sources for pharmaceutical APIs, supported by a large number of WHO-GMP and ISO-certified manufacturers.

• Hikal Ltd. (India)

  Serving as an API supplier, Hikal produces duloxetine hydrochloride for export, emphasizing quality assurance and regulatory compliance.

• CSPC Pharmaceutical Group (China)

  With a strong presence in the API market, CSPC supplies duloxetine hydrochloride meeting international GMP standards.

• Zhejiang Huahai Pharmaceuticals (China)

  A leading manufacturer of APIs including duloxetine hydrochloride, with extensive global export activity certified by various health authorities.

3. Emerging and Regional Suppliers

While the aforementioned companies dominate the market, several emerging manufacturers in Southeast Asia and Eastern Europe are increasingly contributing to the API supply chain, especially as companies seek diversified sources to mitigate geopolitical risks.

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Supplier Qualification and Validation Criteria

Choosing a bulk API source for duloxetine hydrochloride entails rigorous qualification processes. Bidders and manufacturers typically evaluate suppliers based on:

• Regulatory Compliance: ISO certifications, GMP adherence (both WHO-GMP and country-specific GMP), and certifications from authorities like the EDQM or FDA.

• Manufacturing Capacity & Consistency: Volume capability to sustain supply levels without compromising quality.

• Quality Control & Testing: Robust specifications, stability data, and analytical testing protocols to ensure batch-to-batch consistency.

• Traceability and Supply Chain Transparency: Full lot traceability and transparent documentation to facilitate regulatory audits and quality assurance.

• Environmental and Ethical Standards: Compliance with environmental regulations, social responsibility, and good manufacturing practices.

Regulatory Considerations

APIs intended for use in products like Drizalma Sprinkle must meet strict regulatory criteria. Regulatory agencies such as the FDA (U.S.) and EMA (European Union) require the API to conform to GMP standards. In addition, the supplier must provide comprehensive certification, including:

• Certificate of Analysis (CoA)
• Certificate of Suitability (CEP) / Drug Master File (DMF)
• Stability testing data

Manufacturers often rely on suppliers with established inspection histories and ongoing regulatory oversight.

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Impact of API Sourcing on Supply Chain and Drug Approval

Securing APIs from reputable sources preserves the integrity of the finished drug product, meeting required specifications and ensuring patient safety. Supply disruptions from unreliable suppliers can delay drug availability and compromise regulatory approval processes.

Additionally, increasing regulatory scrutiny emphasizes transparency in the API supply chain, influencing procurement decisions. Many manufacturers now prefer suppliers with proven compliance histories and current audits from governance agencies.

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Emerging Trends in API Sourcing

• Localization and Diversification: To mitigate geopolitical and logistical risks, companies diversify API sources across multiple regions.

• Quality Certification Expansion: Suppliers enhancing GMP maturity, including achieving WHO-GMP, US FDA, and European GMP certifications, to access global markets.

• Sustainability Efforts: Emphasis on environmentally sustainable manufacturing practices, which influence supplier selection.

• Digital Supply Chain Monitoring: Utilizing blockchain and digital tracking systems to ensure API traceability and authenticity.

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Conclusion

The bulk API sources for duloxetine hydrochloride, the active pharmaceutical ingredient in Drizalma Sprinkle, are primarily concentrated in India and China, with established manufacturers holding robust quality and regulatory compliance profiles. Companies must rigorously qualify suppliers by assessing GMP certifications, production capacity, quality control practices, and regulatory standings to ensure consistent supply and regulatory approval.

The escalating importance of supply chain resilience, regulatory transparency, and sustainability will shape future sourcing strategies, prompting pharmaceutical companies to develop diversified, compliant, and transparent API sourcing pathways.

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Key Takeaways

• Major API suppliers for duloxetine hydrochloride are based predominantly in India and China, with established GMP-certified manufacturers ensuring consistent quality.

• Supplier qualification involves evaluating GMP compliance, manufacturing capacity, analytical rigor, and regulatory certifications for reliable sourcing.

• Regulatory compliance and certifications such as WHO-GMP, US FDA, and European GMP certifications are critical when selecting API sources, impacting drug approval and market access.

• Supply chain resilience demands diversification and adoption of digital tracking systems, especially in a turbulent geopolitical landscape.

• Sustainable manufacturing practices and transparency are increasingly valued in the API sourcing process, influencing supplier selection and long-term partnerships.

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FAQs

1. What are the primary qualities to look for in a bulk API supplier for duloxetine hydrochloride?
Suppliers should possess GMP certification, consistent batch-to-batch quality, comprehensive analytical validation, traceability systems, and regulatory approvals from recognized authorities (FDA, EMA, WHO).

2. How does API sourcing impact the approval process of Drizalma Sprinkle?
High-quality API sourcing ensures compliance with regulatory standards, supports stability and efficacy data, and facilitates smooth approval processes by demonstrating adherence to quality norms mandated by agencies.

3. Are there regional differences in API quality standards?
Yes, while WHO-GMP, US FDA, and European GMP standards are globally recognized, regional deviations exist. Suppliers certified under these standards are generally preferred for global drug production.

4. What risks are associated with sourcing APIs from emerging suppliers?
Risks include inconsistent quality, inadequate regulatory oversight, supply disruptions, and challenges in compliance verification. Due diligence and qualification audits mitigate these risks.

5. Will API sourcing strategies change post-pandemic?
Yes, the COVID-19 pandemic highlighted supply chain vulnerabilities, prompting companies to diversify sources, incorporate digital tracking, and prioritize suppliers with proven resilience and compliance histories.

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References

[1] Sun Pharma official website, API manufacturing capabilities.
[2] EDQM Certificate of Suitability for duloxetine hydrochloride.
[3] U.S. FDA Drug Master Files and GMP guidelines.
[4] WHO GMP standards for active pharmaceutical ingredients.
[5] Industry reports on global API markets and manufacturing trends.