Suppliers and packagers for ALKINDI SPRINKLE

ALKINDI SPRINKLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876	NDA	Eton Pharmaceuticals, Inc.	71863-109-50	1 BOTTLE, PLASTIC in 1 CARTON (71863-109-50) / 50 GRANULE in 1 BOTTLE, PLASTIC	2020-09-29
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876	NDA	Eton Pharmaceuticals, Inc.	71863-110-50	1 BOTTLE, PLASTIC in 1 CARTON (71863-110-50) / 50 GRANULE in 1 BOTTLE, PLASTIC	2020-09-29
Eton	ALKINDI SPRINKLE	hydrocortisone	GRANULE;ORAL	213876	NDA	Eton Pharmaceuticals, Inc.	71863-111-50	1 BOTTLE, PLASTIC in 1 CARTON (71863-111-50) / 50 GRANULE in 1 BOTTLE, PLASTIC	2020-09-29

Last updated: July 31, 2025

ppliers for the Pharmaceutical Drug: ALKINDI SPRINKLE

Introduction
ALKINDI SPRINKLE is a sensitive pediatric formulation of hydrocortisone designed for children with adrenal insufficiency. Approved by the U.S. Food and Drug Administration (FDA), it is marketed primarily as a dispersible powder that facilitates easier administration for pediatric patients requiring corticosteroid therapy. Understanding the supply chain and key suppliers involved in ALKINDI SPRINKLE production is essential for stakeholders seeking to evaluate manufacturing reliability, market access, and strategic procurement options.

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Manufacturers and Primary Suppliers
The production of ALKINDI SPRINKLE involves a combination of active pharmaceutical ingredient (API) suppliers, excipient providers, formulation specialists, and contract manufacturing organizations (CMOs). The pharmacological integrity and safety profile of ALKINDI SPRINKLE depend on a robust, validated supply chain for each component.

1. Active Pharmaceutical Ingredient (API) Suppliers

Hydrocortisone, the API in ALKINDI SPRINKLE, is sourced from several global suppliers known for regulatory compliance, quality assurance, and manufacturing capacity. Major API manufacturers supplying hydrocortisone for use in pediatric formulations include:

• Hetero Labs Limited (India): As a prominent supplier, Hetero has established a reputation for producing high-quality corticosteroids, including hydrocortisone, compliant with international standards. Their facilities are FDA- and EMA-approved, ensuring supply chain security for global markets.

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): This company supplies hydrocortisone API and has obtained GMP certification. Their broad manufacturing capacity supports supply stability for formulations like ALKINDI SPRINKLE.

• Sandoz (Novartis): As part of Novartis' generics division, Sandoz supplies corticosteroid APIs with stringent quality control, adhering to global regulatory standards. Their mature supply chain contributes to the consistent availability of hydrocortisone.

• Galenica (Switzerland): Known for high-quality active ingredients, Galenica offers hydrocortisone API with rigorous compliance, though supply volume depends on contractual agreements.

2. Excipients and Dispersible Agents

Alkindi Sprinkle requires excipients and dispersing agents compatible with pediatric use, including microcrystalline cellulose, flavoring agents, and fillers such as mannitol or sorbitol. Suppliers include:

• FMC Corporation: Supplies microcrystalline cellulose, a key excipient in pediatric dispersible formulations.

• Roquette Amériques: Provides microcrystalline cellulose and other grades of excipients suitable for pediatric dispersal powders.

• BASF SE: Offers flavoring agents and excipients with pediatric safety profiles.

3. Contract Manufacturing Organizations (CMOs)

Manufacturing ALKINDI SPRINKLE involves specialized facilities capable of handling pediatric dispersible formulations under rigorous quality standards. Notable CMOs and formulation specialists include:

• Wockhardt Ltd.: Known for producing pediatric formulations in compliance with regulatory standards; involved in contract manufacturing for sterile and dispersible medicines.

• Hikma Pharmaceuticals: Operates contract manufacturing units with FDA approval, with experience in corticosteroids and dispersible formulations.

• Recipharm: A global CDMO supporting the pharmaceutical industry with expertise in pediatric and dispersible tablet production.

• Patheon (Thermo Fisher Scientific): Offers formulation and manufacturing services for complex pediatric drugs, including dispersible powders like ALKINDI SPRINKLE.

4. Packaging and Dispensing Suppliers

The final product packaging, critical for maintaining stability and ensuring ease of use for pediatric patients, is supplied by specialized pharmaceutical packaging firms, such as:

• Gerresheimer AG: Supplies child-friendly, airtight, dispersible unit-dose packaging solutions.

• Becton Dickinson (BD): Provides dosing devices and measuring spoons compatible with dispersible formulations.

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Regulatory and Supply Chain Considerations
The supply of ALKINDI SPRINKLE hinges significantly on the geopolitical stability and regulatory compliance of the suppliers. Given its pediatric indication, the drug is subject to strict manufacturing controls, batch testing, and validation to ensure safety and efficacy. The manufacturer, Eli Lilly and Company, relies on a diversified supplier network to mitigate risks associated with supply disruptions.

In recent years, the globalization of pharmaceutical supply chains has increased dependency on international API suppliers, especially those in India and China. Supply chain resilience strategies include multi-sourcing, inventory buffers, and continuous supplier audits to sustain market availability.

Market Dynamics and Strategic Sourcing
The limited number of fully integrated suppliers producing hydrocortisone APIs for pediatric dispersible formulations underscores the importance of strategic procurement. For pharmaceutical companies and healthcare providers, partnerships with reputable API manufacturers and CMOs with proven regulatory compliance enhance reliability and reduce risks of shortages.

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Conclusion
The supply chain for ALKINDI SPRINKLE involves a consortium of international API manufacturers, excipient suppliers, contract manufacturers, and packaging providers. Key suppliers include Hetero Labs, Zhejiang Hisun Pharmaceutical, and Sandoz, among others, operating within a highly regulated environment. Ensuring stability requires diversification, strict quality management, and adherence to global regulatory standards.

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Key Takeaways

• API sourcing is central: Major hydrocortisone API suppliers include Hetero Labs, Zhejiang Hisun, and Sandoz.
• Supply chain diversification mitigates risks of shortages**: reliance on multiple well-regulated suppliers ensures continuous availability.
• Regulatory compliance is mandatory: suppliers must meet international GMP standards to produce pediatric formulations.
• CMO partnerships are vital: specialized manufacturing vendors support the complex dispersible formulation process.
• Global geopolitical factors influence supply stability: monitoring regulatory updates and geopolitical risks ensures proactive management.

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FAQs

1. Who are the primary API suppliers for hydrocortisone in ALKINDI SPRINKLE?
The main API producers include Hetero Labs (India), Zhejiang Hisun Pharmaceutical (China), and Sandoz (Switzerland), all adhering to stringent GMP standards suitable for pediatric formulations.

2. Are there alternative suppliers for hydrocortisone API if the primary sources face shortages?
Yes, other manufacturers such as Galenica (Switzerland) and generic API producers in India or China can serve as alternate supply sources, provided they meet regulatory standards and quality criteria.

3. How does Eli Lilly ensure supply chain resilience for ALKINDI SPRINKLE?
Eli Lilly diversifies sourcing, maintains multi-supplier relationships, conducts regular audits, and imposes strict quality controls to mitigate supply disruption risks.

4. What role do contract manufacturing organizations play in ALKINDI SPRINKLE production?
CMOs handle formulation, manufacturing, and packaging processes, utilizing specialized facilities for pediatric dispersible formulations to guarantee product quality and consistency.

5. How do regulatory requirements affect the sourcing of suppliers for ALKINDI SPRINKLE?
Suppliers must comply with GMP standards, obtain necessary approvals from agencies like the FDA or EMA, and ensure traceability and documentation for all components, especially for pediatric medications.

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References
[1] U.S. Food and Drug Administration (FDA). ALKINDI (hydrocortisone) Sprinkle Caps API Data.
[2] Eli Lilly and Company. Product Information and Supply Chain Details.
[3] Global Pharmaceutical API Directory 2022.
[4] GMP Regulations and Guidelines. WHO, EMA, FDA.