Last updated: May 26, 2026
Cromolyn sodium supplier landscape is fragmented across bulk drug substance (API) and finished-dose manufacturers, with product supply often split by dosage form and market. The actionable way to map suppliers is to anchor on the FDA label’s listed manufacturers/packagers and cross-walk those entities to (1) API sources used in DMFs, (2) CDER/Office of Generic Drugs referencing, and (3) global sites manufacturing Cromolyn sodium bulk and ophthalmic/nasal products.
Who supplies cromolyn sodium (API) and finished dosage forms?
Cromolyn sodium’s supply chain splits into two practical supplier categories for buyers:
- API or drug substance producers (bulk cromolyn sodium)
- Finished-dose manufacturers (ophthalmic solution, ophthalmic ointment, inhalation solution/nebulizer products, and nasal products where marketed)
Because cromolyn sodium is an established product with multiple brands and generics, supplier identification needs to be done at the label level for each dosage form and strength in the specific geography. The most reliable “who supplies” view for commercial sourcing comes from FDA drug product labeling and the corresponding manufacturing/packaging sites shown on the carton and prescribing information.
Finished-dose manufacturer vs. repackager: which entities matter for procurement?
Procurement teams usually distinguish:
- Marketing authorization holder / labeler (US distributor or applicant)
- Manufacturer of record (site that formulates and fills)
- Packager (site that packages final product, sometimes separate)
For cromolyn sodium, many SKUs have different manufacturing sites by NDA/ANDA and dosage strength. Buyers typically require the specific NDC-to-site mapping.
API supply: how suppliers are identified in practice
For API, buyers typically map:
- Drug Substance DMF holders and letter-of-access entries used by each ANDA/NDA applicant
- Third-party importers when US sites do not synthesize API
- Documented suppliers for controlled testing materials (if relevant)
This mapping is usually done through DMF referencing lists, procurement COAs, and labeler-to-manufacturer crosswalks, not by a single public catalog.
What companies supply cromolyn sodium ophthalmic solution and ointment?
Cromolyn sodium ophthalmic products are the most commonly sighted dosage forms in the US market. The supplier set differs by:
- solution vs ointment
- strength (as labeled)
- whether the product is branded or generic
- the labeler/importer for a given NDC
How to build an “ophthalmic NDC to manufacturer site” supplier list
The procurement-grade supplier list is compiled as:
- collect all NDCs for cromolyn sodium ophthalmic solution and ointment
- for each NDC, extract the manufacturer of record and packager from the FDA label (prescribing information and/or Structured Product Labeling)
- de-duplicate manufacturing sites and map them to supplier candidates for audits
This yields a usable shortlist for tendering and dual-sourcing.
Which manufacturers supply cromolyn sodium inhalation solution (nebulizer) products?
Inhalation formulations have a different manufacturing and quality-control footprint than ophthalmic products. Supplier identification depends on:
- the marketed dosage form and concentration
- whether it is a unit-dose inhalation solution
- whether it is tied to an ANDA that sources API from a specific DMF
What to look for when qualifying an inhalation supplier
For nebulizer or inhalation solution supply, qualification typically requires:
- validated fill finish for unit-dose containers
- particle control and container closure integrity
- sterilization method (if applicable) and cleaning validation
- end-to-end stability data aligned to the specific container type
Supplier selection is often constrained by the ability to meet container/closure and leachables requirements for inhalation use.
What suppliers provide cromolyn sodium nasal products?
Nasal cromolyn sodium products, where marketed, usually use a distinct formulation route and different packaging components than ophthalmic or inhalation SKUs. Supplier identification must be tied to the exact NDC(s) and the labeled manufacturing site.
Why nasal products change the supplier set
- nasal dosage form often uses different excipients
- different device and closure system
- different release specifications (spray, droplet size, plume characteristics)
- different microbiological and preservative strategy depending on label
Are there specific bulk API suppliers for cromolyn sodium?
Bulk API suppliers exist globally, but a buyer-grade answer requires mapping from:
- ANDA/NDA drug substance references (DMF holders)
- import records and COA supplier statements
- audit history and qualification documentation tied to a given container form
A generic “API supplier list” without anchoring to DMF referencing and labeler/NDC mapping is not decision-grade for sourcing or litigation readiness.
How do you confirm cromolyn sodium suppliers for regulatory and audit needs?
For high-stakes sourcing, confirmation is done by triangulation:
- FDA label manufacturing and packaging sites per NDC
- ANDA applicant and DMF referencing for drug substance
- quality documents (GMP certificates, CoA, stability protocols)
- historical batch traceability under your requested specification
What documents buyers should request from cromolyn sodium suppliers
- GMP certificate for the manufacturing site
- regulatory history of the site for the relevant product type (ophthalmic vs inhalation vs nasal)
- CoA for representative lots at your target strength and container
- impurity profile and spec limits for cromolyn sodium drug substance if buying API
- change history for formula, process, and primary packaging
What supplier risks exist for cromolyn sodium (single-site dependence, recalls, availability)?
Cromolyn sodium is mature and typically faces periodic supply constraints driven by:
- site-specific batch failures
- container closure transitions
- API sourcing volatility tied to DMF-dependent manufacturing
- seasonal demand spikes for certain therapeutic channels (notably ocular and allergy-related use)
The procurement mitigation is dual-sourcing by NDC and ensuring both suppliers qualify against the same or bridged specifications.
How many suppliers exist for cromolyn sodium in the US by dosage form?
A complete count requires an NDC-level extraction across all marketed strengths and dosage forms, then deduplication by manufacturer/packager site. Without a current NDC crawl of the FDA product database and label manufacturing sections, any number would be non-actionable.
Supplier shortlisting framework for cromolyn sodium procurement
Use this ordering to produce a shortlist that can pass QA and regulatory review:
- NDC-based mapping: list all NDCs for your target dosage form and strength; extract manufacturer and packager sites from FDA labeling
- De-duplicate sites: collapse multiple NDCs that share the same manufacturing site
- API traceability: for each ANDA applicant tied to the NDC, map to the referenced DMF for drug substance where available
- Qualification fit: align your quality requirements to the manufacturing capability (ophthalmic vs inhalation vs nasal)
- Audit readiness: verify GMP status and recent inspection outcomes for the manufacturing sites
- Capacity and lead times: confirm ability to support your forecast and packaging/labeling needs
Key Takeaways
- Cromolyn sodium supply is best managed by dosage-form-specific, NDC-to-manufacturer mapping using FDA label manufacturing and packaging sites.
- API supplier identification requires DMF-based crosswalks, not generic supplier directories.
- Supplier qualification hinges on container closure integrity, fill-finish capability, and traceability by NDC and batch.
- The procurement-grade approach is dual-sourcing by manufacturing site and ensuring regulatory documentation alignment.
FAQs
1) How do I identify the actual manufacturer for a specific cromolyn sodium NDC?
Use the FDA label for that NDC and extract the “Manufactured for” and “Manufactured by/Packaged by” sections, then verify the site on the lot label and CoA.
2) Are cromolyn sodium ophthalmic and inhalation products sourced from the same manufacturing suppliers?
Usually not. Manufacturing capabilities and quality controls differ by dosage form and device/container system.
3) What determines whether an API supplier can support multiple cromolyn sodium generic products?
DMF referencing and the ability to meet the same impurity profile, specifications, and change control requirements demanded by each ANDA applicant.
4) What supplier documentation is most important for QA release of cromolyn sodium?
GMP certificate, CoA (including assay and impurity profile), stability/packaging compatibility evidence, and batch traceability aligned to your exact specification.
5) How do I reduce supply disruption risk for cromolyn sodium?
Pre-qualify at least two manufacturing sites mapped to your NDC(s) and lock in supply agreements tied to those sites, not just the labeler.
References (APA)
- U.S. Food and Drug Administration. “Drug Product Database / Structured Product Labeling (SPL).” FDA.
- U.S. Food and Drug Administration. “FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” FDA.
- U.S. Food and Drug Administration. “Drug Master Files (DMF) and NDA/ANDA referencing information (public-facing resources where applicable).” FDA.
