Suppliers and packagers for ZEMPLAR

Zemplar (paricalcitol) supply is tied to the branded product’s FDA label holder and to the distribution network that fulfills US pharmacy and institutional demand. The key “supplier” parties are (1) the FDA label holder and (2) the manufacturers listed in product labeling and regulatory filings for the marketed strengths and dosage forms.

Who are the Zemplar (paricalcitol) suppliers in the US market?

Answer: Zemplar’s supply chain is anchored by the company listed as the product’s label holder in FDA records, with product manufacture performed by listed contract or in-house manufacturers. Distribution to wholesalers and pharmacies flows through the branded product’s US distribution channels.

What entities typically appear as “suppliers” on Zemplar labeling and FDA records?

In practice, the Zemplar supply chain shows up across three related “supplier” roles:

• Label holder (Marketing authorization holder / NDA holder): the entity responsible for the marketed product in US regulatory terms.
• Manufacturer(s) listed on the label: entities that produce and/or package the drug product for commercial release.
• Distributor(s) for the US: entities that supply finished product to wholesalers, retail pharmacies, group purchasing organizations, and institutions.

What dosage forms and strengths drive separate supplier SKUs?

Zemplar is marketed as paricalcitol for patients with chronic kidney disease and related secondary hyperparathyroidism. Supply is typically managed by strength and presentation, which can map to different manufacturing and packaging lines even when the label holder stays the same.

Which companies manufacture Zemplar (paricalcitol) finished drug product?

Answer: Zemplar manufacturing is performed by the company/companies identified on the FDA label for the marketed strengths and packaging.

How to identify the real manufacturing “supplier” for each Zemplar strength

For Zemplar, the manufacturing supplier is not inferred from “brand ownership.” The manufacturing supplier is what appears on the FDA label under sections that identify manufacture/packaging and contact information for the product. That label information is what matters for:

• vendor qualification and supply assurance
• change-control review for litigation or recalls
• third-party audit readiness for hospital formularies

Where the manufacturing supplier shows up in regulatory documents

The manufacturing supplier can also be reflected in:

• FDA application supplements and manufacturing facility listings
• inspection history for the listed manufacturing sites
• submission references that identify drug product manufacturing/packaging responsibilities

Who distributes Zemplar to wholesalers and pharmacies?

Answer: Finished product distribution is handled through the company and channels tied to the label/distribution listing in FDA labeling and commercial supply agreements, then delivered to wholesale distributors and pharmacy supply chains.

Distribution risk points for hospital procurement

Procurement teams typically screen suppliers on:

• ability to maintain continuity of supply across strengths
• recall history and distribution lot traceability
• lead-time stability for institutional orders

Institutional purchasing and GPO exposure

For hospital systems, Zemplar availability often depends on:

• whether the brand remains on formulary after contracting cycles
• whether wholesalers have current stock and buffer inventory for each strength
• whether substitute products are used during shortage periods

Does Zemplar supply differ by strength or package configuration?

Answer: Yes. Even when the active ingredient is the same, different strengths and packaging configurations can run through distinct manufacturing and packaging workstreams, changing the operational supplier profile.

Operational reasons supplier SKUs can differ

• Different packaging configurations (unit dose vs multi-pack)
• Different bottling or labeling operations
• Different fill-finish campaigns and batch schedules

What are the key supplier alternatives if Zemplar is constrained?

Answer: If Zemplar is constrained, supply alternatives usually fall into two buckets:

1. Same active ingredient alternatives (other paricalcitol branded/authorized products if available)
2. Therapeutic alternatives (other vitamin D analogs or calcimimetics used in secondary hyperparathyroidism regimens)

Why this matters for procurement

If Zemplar supply is interrupted, hospitals often need:

• a formulary switch
• a therapeutic interchange pathway with dosing conversion support
• a procurement plan that ensures continuous dialysis center supply

How strong is Zemplar supply reliability from a supplier perspective?

Answer: Supplier reliability is tied to the manufacturing site(s) and packaging operations listed for the product, plus the distribution channel execution. Any supply issue will map to those named parties.

Supply reliability indicators to track

• Manufacturing inspection outcomes at the listed facilities
• FDA recall and correction postings connected to Zemplar
• Backorder patterns by strength in wholesale channels

What supplier information is most useful for licensing or litigation due diligence?

Answer: For licensing, white-paper diligence, and product liability or IP cases, the operationally relevant supplier facts are:

• the label holder tied to marketing authorization
• the named drug product manufacturer/packager(s)
• lot traceability references used in recall documentation

What to extract from supplier listings

• Legal name of manufacturer site operator
• Packaging responsibilities
• National Drug Code (NDC) coverage by supplier listing (when available in label/regulatory sources)

Key Takeaways

• “Zemplar suppliers” in the US market are defined primarily by the label holder plus the named drug product manufacturer(s) and the distribution channel shown in FDA labeling and regulatory records.
• Supplier responsibility is typically segmented by strength and package configuration, so supply assurance must be assessed at the SKU level.
• For due diligence, the decision-grade supplier data is the label-listed manufacturer/packager(s) and the FDA label holder, not an assumed association from brand ownership alone.

FAQs

1) What company is listed as the label holder for Zemplar (paricalcitol)?
The label holder is the entity listed in the FDA labeling for Zemplar and in the NDA/label record.

2) How do I determine who manufactures Zemplar for a specific NDC?
Use the manufacturer and packaging information printed in the FDA label sections tied to that product configuration and strength, which map to NDC listings.

3) Do Zemplar supply shortages impact all strengths equally?
No. Strength and packaging workstreams can differ, so shortage impact often varies by SKU.

4) What alternative products are used if Zemplar is unavailable?
Clinicians typically switch to other vitamin D analogs or other authorized paricalcitol presentations, depending on formulary and dosing guidance.

5) What supplier details matter most for hospital procurement and recalls?
The manufacturer/packager(s) named on labeling and the distribution lot traceability details tied to Zemplar product configurations.

References (APA)

No sources were provided in the prompt to support a fact-accurate supplier list for Zemplar.