Suppliers and packagers for GASTROCROM

GASTROCROM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viatris Specialty	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479	NDA	Viatris Specialty LLC	0037-0678-96	12 POUCH in 1 CARTON (0037-0678-96) / 8 AMPULE in 1 POUCH (0037-0678-08) / 5 mL in 1 AMPULE	2015-05-01
Viatris Specialty	GASTROCROM	cromolyn sodium	CONCENTRATE;ORAL	020479	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	51525-0470-9	12 POUCH in 1 CARTON (51525-0470-9) / 8 AMPULE in 1 POUCH (51525-0470-8) / 5 mL in 1 AMPULE	2015-10-21

GASTROCROM (cromolyn sodium) Suppliers and Manufacturing Sources: Who Makes Gastrocrom and What to Source for Generic or Contract Supply

Last updated: May 25, 2026

Gastrocrom is the branded form of cromolyn sodium (mast cell stabilizer). The core “supplier” landscape splits into (1) branded product supply by the marketing authorization holder and (2) API and contract manufacturing supply for cromolyn sodium. Public information on full upstream API supplier lists for cromolyn sodium is typically limited, so the most actionable way to map suppliers is through FDA drug-product and label/packaging traceability, plus known contract-manufacturing and API sourcing patterns used for older oral solids.

Which companies supply Gastrocrom cromolyn sodium in the US market?

Direct answer: Gastrocrom’s US market supply is tied to the company listed as the applicant/holder on the US label and to the manufacturer of record for the marketed dosage form. For older, single-API products like cromolyn sodium oral solutions/capsules, the practical “supplier list” for business use is the set of labeled manufacturers and packaging sites named on the package insert and FDA records.

What to look for on the Gastrocrom label to identify the real supplier

• Drug product manufacturer(s): the company named for manufacturing of the finished dosage form.
• NDA holder / distributor: the company responsible for marketing.
• Packaging sites: may differ from the drug-product manufacturing site.
• Label updates: supplier changes can occur without changing the API.

How the Orange Book listing constrains supplier mapping

Orange Book entries identify:

• the drug product (strength, dosage form)
• and the patent and exclusivity context that can affect generic supply timelines
• they do not always provide the complete API vendor list, but they let you anchor the product-manufacturing parties to the labeled record.

Who supplies cromolyn sodium API used to make Gastrocrom?

Direct answer: For Gastrocrom-equivalent products, the API supplier pool generally consists of API manufacturers of cromolyn sodium and, depending on regulatory posture, multiple secondary sources used by contract manufacturers. Public “vendor lists” for the API are rarely disclosed at the level of named companies on the label, so supplier identification is usually built from:

• FDA manufacturing site data for the finished product
• supplier qualification disclosures in DMFs/ASMFs and supply chain documentation
• historical procurement patterns for older oral mast cell stabilizers

Typical cromolyn sodium supply chain structure

• API: cromolyn sodium, typically supplied as a crystalline API under GMP.
• Finished product: oral solution or capsule/tablet dosage forms made by a contract manufacturer or in-house facility.
• Packaging: sometimes outsourced to specialized packaging plants.

What contract manufacturing options exist for cromolyn sodium oral dosage forms?

Direct answer: Contract manufacturing for an older, non-biologic oral mast cell stabilizer is commonly handled by CDMOs that support:

• aqueous solution filling (for oral liquids)
• capsule filling or tablet compression (depending on the dosage form)
• stability and container closure system qualification

What matters for supplier selection in Gastrocrom-like manufacture

• Dosage form capability: oral solution filling vs solid oral manufacturing
• Container closure: compatibility with cromolyn sodium and preservative system (if applicable)
• GMP history for older oncology/allergy class drugs: oral solids/liquids, batch release testing, impurity control
• Analytical method readiness: cromolyn assay and related substances methods suitable for older API specifications

How do you verify the supplier for Gastrocrom you are buying today?

Direct answer: Trace the supplier using the package insert label and the manufacturer-of-record named on the FDA-listed drug product. For regulated procurement, the supplier identity is anchored to:

• the manufacturer on the US label
• batch release documentation tied to the labeled manufacturing site
• NDC-specific labeling

Best-practice procurement checks

• Match the NDC to the labeled manufacturer on the current package.
• Require COA from the seller and reconcile manufacturing site in batch paperwork.
• Confirm that the finished product is made under the same labeled facility name and that the packaging is consistent with the NDC label.

How does patent status affect supplier entry for cromolyn sodium products?

Direct answer: Gastrocrom’s exclusivity and patent estate is the legal framework that can restrict generic entry, but supplier behavior after entry is governed mainly by market pull, procurement economics, and ability to secure regulatory acceptance for an ANDA product.

What to check for generic entry risk

• Whether the product has any remaining Orange Book patents for:
  • active ingredient
  • formulation
  • method of use
  • packaging
• Whether any exclusivity still blocks approval dates for additional competitors.

What formulation suppliers and dosage-form variants change supplier landscapes?

Direct answer: Even with the same API (cromolyn sodium), the supplier pool can differ by dosage form:

• oral solution suppliers are different from capsule suppliers
• formulation and container systems can drive separate manufacturing qualification needs
• bioequivalence and stability requirements change the CDMO and QC supplier set

Dosage-form mapping

• Gastrocrom branding historically includes oral formulations (depending on NDC and time period). Each NDC corresponds to a specific label configuration, which maps to a specific manufacturer-of-record.

Supplier landscape for biosimilars or biologics: does it apply to Gastrocrom?

Direct answer: No. Gastrocrom is a small molecule (cromolyn sodium), not a biologic. Biosimilar pathways do not apply to supplier entry; the relevant pathway is standard small-molecule generic development (ANDA/505(j)) where applicable.

Comparative supplier exposure: Gastrocrom vs other cromolyn sodium generics

Direct answer: Supplier concentration is usually higher for older originator brands, while generic competitors broaden the supplier base. The key operational comparison is:

• number of ANDA-labeled manufacturers per dosage form
• availability across NDCs
• procurement leverage based on generic supply stability

What operational procurement buyers compare

• number of qualified manufacturers
• lead times and batch sizes
• price volatility and supply continuity
• QC method robustness and impurity control capability

Key Takeaways

• “Suppliers for Gastrocrom” should be treated as two layers: drug-product manufacturers labeled on the current US product and upstream cromolyn sodium API/CDMO supply that supports those manufacturers.
• The actionable supplier list for immediate sourcing is the manufacturer-of-record and packaging site named on the Gastrocrom label for the specific NDC.
• Generic and contract supply viability depends on dosage-form capability and regulatory standing tied to Orange Book and ANDA approvals, not on biosimilar pathways.

FAQs

1. Which manufacturer-of-record is listed on Gastrocrom packages for a specific NDC?
2. Do Gastrocrom suppliers change when NDCs or label holders change?
3. Are cromolyn sodium API suppliers disclosed in US labeling or Orange Book entries?
4. What manufacturing capability is required to make cromolyn sodium oral solution versus capsules?
5. Does Orange Book status constrain supplier availability for cromolyn sodium generics?

References

1. FDA Orange Book. Drug Products Approved for Marketing. (Accessed 2026-05-26).
2. FDA Labeling for Gastrocrom (cromolyn sodium). (Accessed 2026-05-26).