RABEPRAZOLE SODIUM: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alkem Labs Ltd	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	208644	ANDA	A-S Medication Solutions	50090-4751-0	30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4751-0)	2018-04-27
Alkem Labs Ltd	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	208644	ANDA	A-S Medication Solutions	50090-4751-1	90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4751-1)	2018-04-27
Alkem Labs Ltd	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	208644	ANDA	St. Mary's Medical Park Pharmacy	60760-560-07	7 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-560-07)	2019-09-10
Alkem Labs Ltd	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	208644	ANDA	St. Mary's Medical Park Pharmacy	60760-560-30	30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-560-30)	2019-09-10
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: April 23, 2026

Which suppliers make or source rabeprazole sodium (API)?

Rabeprazole sodium is supplied through a layered chain: API manufacturers (rabeprazole sodium as drug substance), API distributors/traffickers, and formulation manufacturers (rabeprazole sodium tablets) that may also supply back into trade. The most defensible supplier set for R&D and commercialization decisions comes from entities that (1) list rabeprazole sodium API in their product portfolio and (2) participate in regulatory supply chains (eg, DMF holders, CEP holders, or approved API listings).

Actionable supplier verification criteria for rabeprazole sodium API

Regulatory dossier status: DMF/ASMF holder name on-file with the target market authority, or CEP from an issuing authority.
Quality system coverage: ISO 9001 and GMP manufacturing for API, plus auditability (site-level).
Specification fit: intended grade (pharmaceutical grade), particle size (if relevant for formulation), polymorphic form controls where applicable, and residual solvent limits.
Supply form: typically “rabeprazole sodium” (drug substance). If an entity only sells “rabeprazole” free base or “rabeprazole tablets,” they may not qualify as an API supplier.
Packaging and traceability: drum/bag grades, batch traceability, and COA release process.

Supplier categories you can map to actual sourcing lanes

Direct API manufacturers: sell rabeprazole sodium API as a raw material.
API trading/distributors: source from manufacturers and resell; useful for short cycle procurement but carries traceability risk.
Formulation players with API capability: some generic tablet manufacturers supply API or contract manufacturing for other brands.

What suppliers typically appear in rabeprazole sodium API supply chains?

Below is the supplier landscape by company type that is commonly present in rabeprazole sodium trade and dossier ecosystems. Use these names as starting points only after reconciling against the verification criteria above for the specific market and grade.

Indian and global API manufacturing ecosystem

Commonly encountered rabeprazole API suppliers and their API supply presence (API or dossier footprint) include:

Ajanta Pharma
Aurobindo Pharma
Biocon (API manufacturing presence across multiple launches; verify dossier and product-grade)
Cipla (API footprint; verify rabeprazole sodium API listing)
Dr. Reddy’s Laboratories
Hetero Drugs / Hetero Labs
Intas Pharmaceuticals (verify drug substance listing)
Lupin
Mylan (Viatris) (API footprint via prior portfolio; verify current rabeprazole sodium API availability)
Sun Pharma
Teva (verify current drug substance supply role)

Specialty generic and distribution lanes

These are often part of rabeprazole sodium supply through distribution networks rather than primary API manufacturing (verify the exact supply form and regulatory status):

BASF / pharmaceutical distribution networks (verify whether rabeprazole sodium is sold as API vs intermediates in the specific region)
Global API distributors (verify CoA, DMF holder alignment, and site of origin)

Which supplier proof points should be required before awarding business?

For rabeprazole sodium API, procurement-grade diligence should lock to the following documented proof points:

Minimum pre-award documentation

Latest COA for the exact strength/grade requested (drug substance level).
Manufacturing site listed for the batch (not only corporate identity).
DMF/ASMF or CEP reference matching the supplier entity.
Spec sheet including identity, assay, impurity thresholds, water content (if specified), and residual solvent limits.
Stability package summary (accelerated and long-term) covering the proposed retest period.

Practical acceptance thresholds (what to confirm)

Impurity panel alignment with pharmacopeial and regulatory expectations for the target market.
Sodium counterion specification consistency (rabeprazole sodium is not always substitutable with different salt forms).
Polymorph/process controls if the supplier controls solid form for bioavailability.

What documentation differentiates a true rabeprazole sodium API supplier from a reseller?

Use this decision table to filter supplier candidates fast.

Supplier claim	What to ask	What to validate
“We supply rabeprazole sodium API”	Provide COA for rabeprazole sodium (API)	COA shows drug substance, not formulation/tablet material
“We have a DMF”	DMF/ASMF number and holder name	Holder name matches supplier contract entity and site
“We have GMP”	Site-level GMP certificate	Certificate covers API manufacturing, not only warehousing
“We can deliver quickly”	Origin and batch traceability	Batch origin is traceable to the API manufacturing site
“Same as reference grade”	Full spec sheet and impurity profile	Spec sheet matches target market acceptance criteria

How to build a defensible supplier shortlist (workable path)

For an investment-grade shortlist, reduce the universe to suppliers who can pass the following two-step filter:

1) Regulatory alignment filter

Entity is a known DMF/CEP holder or supplies via a dossier that matches the intended market.
Confirm that “rabeprazole sodium” is in the dossier as the drug substance (not an intermediate).

2) Operational and quality filter

Site has active API GMP manufacturing for the drug substance.
Provides batch-level traceability and standard pharmaceutical documentation.

What should you expect in supply lead times and commercial terms?

Typical rabeprazole sodium API procurement patterns:

Lead time is usually determined by batch scheduling and QA release, not corporate sales availability.
MOQ and pricing tend to vary by whether the supplier is selling a standard commodity grade or a dossier-specific grade tied to regulatory filings.
Incoterms are commonly negotiated at contract stage (EXW/FCA and FOB terms are common for India-based exports; CIF/DDP vary by distributor).

What supplier risks matter most for rabeprazole sodium?

Primary risks in rabeprazole sodium supply tend to be:

Traceability gaps when using brokers/distributors without site-level batch origin confirmation.
Spec mismatch (impurity limits and polymorph/process controls) leading to failed incoming quality.
Regulatory misalignment where dossier status exists under a different entity name or manufacturing site.

Which formulation manufacturers are the practical end-demand suppliers (tablet brands)

If the buying need is actually dosage-form supply rather than API, rabeprazole sodium tablets are widely manufactured by global and Indian generic companies. For formulation supply, validate:

Bioequivalence and approval pathway in the target market.
Tablet spec (disintegration, dissolution profile) and packaging configuration.

Key generic formulation groups with broad PPI coverage include:

Ajanta Pharma
Aurobindo Pharma
Cipla
Dr. Reddy’s Laboratories
Hetero Drugs
Lupin
Sun Pharma
Teva
Viatris (Mylan)

Key Takeaways

Rabeprazole sodium supply is structured through API manufacturers and dossier ecosystems; resellers can add speed but must prove site-level batch origin and dossier alignment.
A procurement-grade shortlist requires COA + drug substance specification + batch traceability + DMF/CEP evidence tied to the supplier’s contract entity.
If you need tablets rather than API, validate approval status and dissolution/disintegration specs in the target market, not just brand equivalence.

FAQs

1) Can I use rabeprazole free base instead of rabeprazole sodium?

No, not as a drop-in substitute for drug substance procurement. The sodium salt form has different specification requirements and may impact formulation performance; confirm the exact chemical form in the dossier and spec.

2) What is the fastest way to qualify a new supplier for rabeprazole sodium API?

Require COA, drug substance spec sheet, and batch origin at the time of first sample, then reconcile DMF/CEP holder identity and manufacturing site before scale procurement.

3) Should I buy through a distributor or directly from an API manufacturer?

Distributors can work for short-cycle needs, but award business only after confirming site-level origin, traceability, and dossier alignment. Direct manufacturers reduce traceability variance.

4) What documents should be non-negotiable for API purchasing?

Batch COA, spec sheet, GMP certificate at the manufacturing site, and dossier evidence (DMF/ASMF or CEP) tied to the contract entity and intended market.

5) Which market factor changes the supplier choice for rabeprazole sodium?

Market dossier requirements change the acceptable supplier entities and sites, especially when filings are held under specific legal entities and manufacturing addresses.

References

[1] U.S. Food and Drug Administration. “Drugs@FDA: Rabeprazole Sodium (reference listings and regulatory context).” FDA, accessed 2026.
[2] European Medicines Agency. “European public assessment reports (EPAR) and medicine dossier context for rabeprazole-containing products.” EMA, accessed 2026.
[3] United States Pharmacopeia (USP). “Rabeprazole sodium monograph and quality specifications.” USP, accessed 2026.

Suppliers and packagers for RABEPRAZOLE SODIUM