Last updated: April 24, 2026
What is PROCARDIA XL, and who manufactures it?
PROCARDIA XL is an extended-release oral tablet containing nifedipine. In the US, the product is marketed by Bayer under the brand name PROCARDIA XL. Bayer is the label holder in US product labeling and distributor/manufacturer chain for the branded drug.
Manufacturer / Labeling party on US prescribing information:
- Bayer HealthCare Pharmaceuticals Inc. (US label holder for brand materials)
Who are the suppliers in the manufacturing and commercial chain?
For brand-name PROCARDIA XL, the supplier set that matters in practice is:
- Label holder / commercial brand owner: Bayer (US)
- Finished-dose manufacturer: typically listed in the prescribing information/labeling as the manufacturer of record for the commercial product
- API source and excipient sourcing: rarely disclosed comprehensively in public brand labels; these are typically reflected in generic ANDA supply chains or in supplier qualification files, not in consumer-facing labeling
The public record commonly supports the following high-confidence supplier identification from labeling:
US brand supplier identification (labeling chain)
| Role |
Entity |
Evidence basis |
| Brand / US label holder |
Bayer HealthCare Pharmaceuticals Inc. |
Listed as US label holder on PROCARDIA XL prescribing information (brand product labeling) |
Are there multiple suppliers or only one?
For the branded extended-release nifedipine product, supplier responsibility can be split across:
- Market authorization owner (label holder): Bayer
- Manufacturing sites / contract manufacturers: can vary by lot and distribution channel, even when the label holder stays the same
Public labeling generally pins down the label holder more reliably than it pins down every upstream API/excipient supplier.
What upstream suppliers are involved (API and key excipients)?
Public, named upstream suppliers for the nifedipine API and excipients are not consistently disclosed in brand prescribing information. In practice, the upstream sourcing profile for PROCARDIA XL tends to look like this:
- API supplier: nifedipine API is produced by contract and/or qualified API manufacturers that supply multiple finished-dose manufacturers and generic entrants. Named API suppliers are not usually identified on brand labels.
- Excipients and extended-release matrix components: supplier names are typically not disclosed on brand labeling. Extended-release systems often rely on controlled-release polymers, film formers, and tablet excipients that come from specialty chemical suppliers qualified by the finished-dose manufacturer.
Because the request is specifically “suppliers,” the only supplier names that can be stated with hard grounding from brand labeling are those tied directly to the product’s labeled manufacturer/label holder.
What is the supplier risk profile for PROCARDIA XL?
PROCARDIA XL uses an extended-release (ER) formulation, which increases supply sensitivity to:
- Controlled-release excipient availability (polymer-grade materials, coating systems)
- Finished-dose process capacity at qualified sites
- Lot-to-lot consistent release specification
From a business perspective, supplier concentration risk typically shows up in:
- Formulation materials that are grade- and process-specific
- Contract manufacturing capacity for ER tablets (tablet compression/coating/controls)
How can you identify suppliers from the regulatory record?
For brand PROCARDIA XL, the most actionable public supplier identification typically comes from:
- US prescribing information and FDA labeling (label holder and sometimes manufacturer of record)
- NDC labeler / manufacturer entries in commercial product databases (used to map “manufacturer of record” and sometimes packaging sites)
- ANDA filings for nifedipine ER (these often disclose more on the generic product manufacturing chain than the brand does)
What named supplier entities can be stated directly from PROCARDIA XL labeling?
Named entity (US):
- Bayer HealthCare Pharmaceuticals Inc. (US label holder)
No other upstream supplier names can be stated from public brand labeling with the same level of certainty.
Key Takeaways
- PROCARDIA XL is a Bayer-branded extended-release nifedipine tablet.
- The publicly identifiable supplier in US labeling is Bayer HealthCare Pharmaceuticals Inc. as the US label holder for PROCARDIA XL.
- Upstream API and excipient suppliers are typically not disclosed in brand prescribing information, so supplier mapping beyond the label holder requires regulatory product trace sources (labeler/manufacturer of record or ANDA supply chains).
FAQs
1) Who is the label holder for PROCARDIA XL?
Bayer HealthCare Pharmaceuticals Inc.
2) Is PROCARDIA XL manufactured by Bayer directly?
The label holder is Bayer. The specific finished-dose manufacturing site(s) can vary by lot and are typically listed as manufacturer of record in labeling and commercial product documentation.
3) Who supplies the nifedipine API for PROCARDIA XL?
API supplier names are not consistently disclosed in PROCARDIA XL brand labeling.
4) Who supplies the extended-release excipients for PROCARDIA XL?
Excipients and controlled-release materials supplier identities are generally not disclosed in public brand labeling.
5) What is the best public source to map PROCARDIA XL suppliers?
US prescribing information and label/manufacturer of record fields are the most reliable starting point for supplier chain identification.
References
[1] FDA. Procardia XL (nifedipine) Prescribing Information. US labeling for brand product.
