Last Updated: May 10, 2026

Suppliers and packagers for CALCIUM GLUCONATE


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CALCIUM GLUCONATE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Amneal CALCIUM GLUCONATE calcium gluconate SOLUTION;INTRAVENOUS 216611 ANDA Amneal Pharmaceuticals Private Limited 80830-1672-2 10 VIAL in 1 CARTON (80830-1672-2) / 10 mL in 1 VIAL (80830-1672-1) 2024-05-13
Amneal CALCIUM GLUCONATE calcium gluconate SOLUTION;INTRAVENOUS 216611 ANDA Amneal Pharmaceuticals Private Limited 80830-1672-5 25 VIAL in 1 CARTON (80830-1672-5) / 10 mL in 1 VIAL (80830-1672-1) 2024-05-13
Amneal CALCIUM GLUCONATE calcium gluconate SOLUTION;INTRAVENOUS 216611 ANDA Amneal Pharmaceuticals Private Limited 80830-1673-2 10 VIAL in 1 CARTON (80830-1673-2) / 50 mL in 1 VIAL (80830-1673-1) 2024-05-13
Amneal CALCIUM GLUCONATE calcium gluconate SOLUTION;INTRAVENOUS 216611 ANDA Amneal Pharmaceuticals Private Limited 80830-1673-5 25 VIAL in 1 CARTON (80830-1673-5) / 50 mL in 1 VIAL (80830-1673-1) 2024-05-13
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Who Supplies Calcium Gluconate for Pharmaceutical Use? (API and Finished-Form Materials)

Last updated: April 24, 2026

What are the core supplier categories for pharmaceutical calcium gluconate?

Calcium gluconate for pharmaceutical use comes through two supply tracks:

  1. API-grade calcium gluconate (active ingredient)
    Sold as calcium gluconate (commonly in monohydrate form for bulk API markets) to finished-dose manufacturers.

  2. Finished pharmaceutical products (injectables and tablets)
    Packaged products sold under specific market authorizations (varies by country) to hospitals and pharmacies.

The supply chain is fragmented because calcium gluconate is used globally in multiple dosage forms, and because pharmacopeia-compliant manufacturers range from large industrial chemical firms to specialized sterile-product suppliers.

Which suppliers matter in global calcium gluconate supply?

Below are major, widely active suppliers and manufacturers that consistently appear across global regulatory and commercial channels for calcium gluconate (API and pharmaceutical-grade supply). This list is structured for sourcing decisions by: (i) manufacturing footprint, (ii) typical product form, and (iii) how these firms position for pharma supply.

Large chemical and pharma-chemical producers (API and bulk pharma grade)

Supplier Supply positioning Typical relevance to pharma sourcing
Brenntag Global distribution and sourcing platform Bulk pharma-grade logistics, multi-origin sourcing for API procurement
Beijing Kaisheng Specialty chemical manufacturing Calcium salts and pharmaceutical intermediates ecosystem; used in pharma supply channels
Jiangsu Huishan API and chemical intermediate manufacturer Bulk calcium gluconate supply for downstream formulation
Global Calcium Company Calcium salt supply Bulk production and supply continuity for pharmaceutical customers
Hebei Xinhe Bulk chemical manufacturing Calcium salt supplier with pharma-grade distribution pathways

Sterile/injectable product manufacturers (finished dosage supply)

Supplier Supply positioning Typical relevance to pharma sourcing
B. Braun Hospital injectable portfolio Calcium gluconate injection supply for institutional channels
Fresenius Kabi IV and hospital pharmaceuticals Injectable calcium salts supply under established distribution networks
Hospira (Pfizer legacy footprint in many markets) Injectable generics and hospital products Calcium gluconate injection availability where legacy authorizations persist
Teva Generics and injectables Market-dependent availability of calcium gluconate dosage forms
Sandoz Generics and sterile products Market-dependent sterile supply for calcium gluconate formulations

China-based pharma-grade manufacturers with international commercial presence (API and/or pharma-grade bulk)

Supplier Supply positioning Typical relevance to pharma sourcing
Shanghai Sinops Pharma chemical and API production Calcium salts including calcium gluconate for pharma supply chains
Shandong Jincheng Calcium salt manufacturing Bulk supply for downstream pharma formulation in multiple dosage forms
Tianjin Tianyao Bulk pharma chemicals Pharma-grade calcium salt manufacturing presence

Use note for procurement: In practice, “supplier” for calcium gluconate is often either (a) the API manufacturer or (b) a pharma distributor that certifies and supplies based on pharmacopeial compliance. For sterile products, supplier means the marketing authorization holder and/or manufacturer of record for the injection.

What do you need to verify when selecting a supplier?

Pharmaceutical buyers typically screen calcium gluconate suppliers on the following hard criteria.

Quality and regulatory

  • Pharmacopeia compliance
    Calcium gluconate used in pharma commonly needs USP/NF and/or Ph. Eur. alignment, plus vendor-specific COA and impurity profiles.
  • Sterility/pyrogen controls (for injections)
    For calcium gluconate injection, sterile manufacturing sites must document sterility assurance, endotoxin controls, and container closure integrity.

Documentation and batch support

  • Batch COA with identification tests, assay, impurities, and heavy metals.
  • GMP status aligned to the buyer’s target markets.
  • Stability data for the finished form (injectable or tablet) if sourcing dosage forms rather than API.

Supply continuity

  • Multi-source capability because calcium gluconate demand rises in periodic shortages for emergency IV usage in some regions.

How do distributors fit into the supplier landscape?

Distributors often act as the interface between pharma manufacturers and API producers, offering:

  • Multi-origin supply (several manufacturers behind one commercial relationship)
  • Faster logistics and contracting flexibility
  • COA consolidation and documentation management

In a sourcing cycle, this reduces time-to-quote but does not eliminate the need to verify the actual manufacturer of record and the lot’s origin.

Common product forms and how that changes supplier selection

Supplier lists differ depending on whether you need API or a marketed drug product:

If you need API (bulk calcium gluconate)

  • Focus on API manufacturers and chemical producers with documented pharma-grade capability.
  • Confirm the exact salt form (commonly monohydrate vs anhydrous) and spec limits.

If you need an injectable

  • Focus on sterile product manufacturers and marketing authorization holders in the target country.
  • Confirm presentation (strength, container type, fill volume) and labeling language.

If you need tablets

  • Focus on formulation and tableting manufacturers or companies holding tablet authorizations in the region.

Where shortages or demand spikes change purchasing behavior

Calcium gluconate is used in acute care settings, so procurement patterns tend to favor:

  • Established injectable suppliers during emergency surges
  • API multi-sourcing during supply volatility at the bulk-material level
  • Contract packaging arrangements where local regulatory requirements mandate local release

Key Takeaways

  • Calcium gluconate supply splits into API manufacturers, pharma distributors, and finished sterile product suppliers.
  • For sterile calcium gluconate injection, prioritize hospital injectable portfolio suppliers and the manufacturer of record behind the marketed product.
  • For API, prioritize pharma-grade compliance and batch documentation over broker-only listings.
  • In procurement, distributors like Brenntag often provide faster commercial access, but the underlying manufacturing site still governs quality and regulatory acceptability.

FAQs

1) Is calcium gluconate supply mainly dominated by API manufacturers or finished-product companies?

It is split. API supply is driven by bulk chemical manufacturers and pharma-grade producers, while injectable supply is dominated by companies with sterile manufacturing and marketed product authorizations.

2) Do distributors count as suppliers for pharma sourcing?

They often count for commercial procurement, but pharma qualification still requires verification of the actual manufacturing origin and associated GMP/COA documentation.

3) What matters most for calcium gluconate injection procurement?

The sterile manufacturing site, endotoxin/sterility assurance documentation, and the exact presentation under local authorization.

4) Are tablet and injectable suppliers interchangeable?

No. Tablet and injectable supply chains differ by formulation technology, regulatory requirements, and sterile controls.

5) Why do buyers multi-source calcium gluconate?

Demand can spike in acute care settings, and bulk materials can face transient supply constraints, so multi-sourcing reduces lead-time and continuity risk.


References

[1] European Pharmacopoeia (Ph. Eur.). Calcium gluconate monographs and general quality requirements. European Directorate for the Quality of Medicines (EDQM).
[2] U.S. Pharmacopeia (USP) and USP-NF. Calcium gluconate monograph and specifications. U.S. Pharmacopeial Convention.
[3] World Health Organization (WHO). Pharmaceutical quality guidance and GMP expectations for pharmaceutical supply chains. WHO.
[4] Brenntag. Company information and distribution footprint for specialty chemicals and healthcare ingredients. Brenntag.
[5] B. Braun. Product portfolio information for hospital injectables. B. Braun.
[6] Fresenius Kabi. Hospital injectable portfolio information. Fresenius Kabi.
[7] Pfizer (Hospira legacy). Injectable generics portfolio footprint by market where applicable. Pfizer.

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