Suppliers and packagers for SIKLOS

SIKLOS

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Theravia	SIKLOS	hydroxyurea	TABLET;ORAL	208843	NDA	Medunik	71770-105-60	1 BOTTLE in 1 CARTON (71770-105-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2020-10-15
Theravia	SIKLOS	hydroxyurea	TABLET;ORAL	208843	NDA	Medunik	71770-120-30	1 BOTTLE in 1 CARTON (71770-120-30) / 30 TABLET, FILM COATED in 1 BOTTLE	2018-04-15

Suppliers and packagers for SIKLOS

Last updated: May 26, 2026

SIKLOS suppliers (hydroxyurea 300 mg tablets) and sourcing landscape: Who makes it, ships it, and what to watch in IP/quality

Executive summary: SIKLOS (hydroxyurea 100 mg and 1,000 mg tablets; marketed as a branded antineoplastic in sickle cell disease) is manufactured and distributed through a branded supply chain that typically includes the marketing authorization holder, contract manufacturers for solid oral dosage, and distributors handling wholesaling and hospital/retail fulfillment. The supplier list that matters for procurement, contracting, and substitution decisions is: (1) the listed manufacturer(s) on the FDA label and (2) any contract manufacturing sites feeding the market. A complete, accurate supplier roster by company name and site cannot be produced from the information provided.

What companies are suppliers for SIKLOS hydroxyurea tablets in the US?

A procurement-grade “supplier” answer for SIKLOS should map to FDA label manufacturing information and US distribution channels. For a branded solid oral drug, the practical supplier set usually includes:

Manufacturer(s) listed on the FDA label

• The drug label identifies the company(ies) responsible for manufacturing the drug substance and/or the finished drug product.
• For solid oral dosage forms, the most decision-relevant entry is the finished drug product manufacturer and manufacturing site(s) listed on the label.

Who distributes SIKLOS

• In the US, distribution is generally executed by the marketing authorization holder or its logistics partner(s), then sold to wholesalers, group purchasing organizations, hospital pharmacies, and specialty distribution networks.

Contract manufacturers and packaging sites

• Even when the label names the drug product manufacturer, packaging operations (blistering, bottle filling, secondary packaging) can be separate site suppliers.

Bottom line: Without the FDA label manufacturer/distributor fields for SIKLOS, a named-company supplier list cannot be stated accurately.

What suppliers make SIKLOS 100 mg vs 1,000 mg tablets?

SIKLOS has multiple strengths, and sourcing can split by:

• finished dosage strength (different granulation and tablet compression runs)
• packaging configuration (bottle versus blister)
• batch release and QA release responsibilities

Procurement risk: If different strengths come from different sites, a supply disruption at one facility can create strength-specific shortages. A strength-by-strength supplier mapping requires the label’s “manufactured for” and “manufactured by” sections and/or current GMP site disclosures.

Which raw material suppliers support SIKLOS (hydroxyurea API and excipients)?

A robust supplier model for tablets includes:

• hydroxyurea active pharmaceutical ingredient (API) suppliers
• excipient suppliers (tableting and coating components)
• ink and imprint suppliers (if applicable)
• packaging suppliers (bottles, closures, blister foils)

Procurement relevance: API supply risk and excipient supply risk affect batch release timelines, availability, and cost.

Constraint: Named API and excipient suppliers cannot be listed without SIKLOS-specific API/excipient supply-chain disclosures (typically not public in a simple way outside controlled disclosures, DMFs, or label-linked manufacturing details).

What is the Orange Book status of SIKLOS and does it affect supplier choices?

Supplier choices are shaped by:

• patent-protected manufacturing processes and formulations
• exclusivity tied to branded drug approval
• any authorized generics or license-based production

But: “Orange Book status” affects who can make a generic, not which contract manufacturers can produce the branded drug. Still, branded supply continuity can be influenced by legal constraints if there is a contract manufacturing relationship with a party that also produces competitor products.

Constraint: A definitive Orange Book status mapping needs the specific FDA application listing for SIKLOS and the associated patents and exclusivities. No patent listing inputs were provided.

Who are SIKLOS contract manufacturers for finished tablets and packaging?

For solid oral drugs, the supplier set usually splits as follows:

1. API manufacturer(s)
2. tablet bulk manufacturer and compression site (drug product site)
3. packaging site (bottle/blister line)
4. QA release site (often co-located, sometimes separate)

Constraint: Named contract manufacturing sites for SIKLOS cannot be produced without label-linked manufacturer entries.

What distributors supply SIKLOS to hospitals and specialty pharmacies?

Distribution in sickle cell disease is typically concentrated through:

• specialty distributors
• hospital pharmacy supply chains
• wholesalers covering GPO and 340B-affiliated institutions

Constraint: Without the marketing authorization holder and label distributor details for SIKLOS, a named distributor list cannot be stated.

How do SIKLOS shortages map to supplier or site-specific risk?

When shortages occur for solid oral drugs, they usually trace to:

• batch rejection or delayed QA release at the drug product site
• API supply disruption
• packaging line failures or packaging material shortages
• raw material lead-time constraints impacting critical quality attributes

Constraint: A supplier-site disruption map requires (a) documented shortage notices, (b) FDA communications, or (c) supply-chain statements tied to SIKLOS. None were provided.

Comparison: how supplier risk differs for SIKLOS versus other hydroxyurea brands

Hydroxyurea has multiple branded and generic products globally. Supplier risk differs by:

• tablet strength and excipient package complexity
• number of manufacturing sites feeding US demand
• whether the drug is produced on a single-line bottleneck
• regulatory inspection history of manufacturing sites

Constraint: A direct comparison needs the other products’ label manufacturers and any FDA shortage history.

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Key Takeaways

• A procurement-grade “SIKLOS suppliers” list must be built from the FDA label manufacturing/distributor fields.
• With only the product name provided, a complete and accurate supplier roster by company and site cannot be generated.
• Supplier risk for solid oral drugs is site- and strength-dependent, so mapping 100 mg vs 1,000 mg strength sources is essential for continuity planning.

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FAQs

1. How do I confirm the SIKLOS manufacturer on the US label?
2. Are the API and tablet suppliers for SIKLOS always the same company?
3. Can SIKLOS 100 mg and 1,000 mg tablets come from different manufacturing sites?
4. Does SIKLOS supplier availability track FDA drug shortage notifications?
5. What documentation do buyers request from SIKLOS suppliers (CoA, GMP, and site verification)?

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References (APA)

1. FDA. (n.d.). SIKLOS prescribing information (label/manufacturing and distribution sections). U.S. Food and Drug Administration.