Suppliers and packagers for generic pharmaceutical drug: MONTELUKAST SODIUM

MONTELUKAST SODIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ajanta Pharma Ltd	MONTELUKAST SODIUM	montelukast sodium	GRANULE;ORAL	203438	ANDA	Ajanta Pharma USA Inc.	27241-015-31	30 GRANULE in 1 CARTON (27241-015-31)	2015-08-13
Aurobindo Pharma Ltd	MONTELUKAST SODIUM	montelukast sodium	GRANULE;ORAL	213471	ANDA	Aurobindo Pharma Limited	59651-329-30	30 PACKET in 1 CARTON (59651-329-30) / 1 GRANULE in 1 PACKET (59651-329-05)	2020-02-18
Torrent	MONTELUKAST SODIUM	montelukast sodium	GRANULE;ORAL	210431	ANDA	Torrent Pharmaceuticals Limited	13668-531-94	30 PACKET in 1 CARTON (13668-531-94) / 500 mg in 1 PACKET (13668-531-11)	2017-03-30
Organon	SINGULAIR	montelukast sodium	GRANULE;ORAL	021409	NDA	Organon LLC	78206-171-01	30 PACKET in 1 CARTON (78206-171-01) / 1 GRANULE in 1 PACKET	2021-06-01

Montelukast Sodium Suppliers: API and Finished-Dose Manufacturers, Key Regions, and Supply-Chain/IP Watchpoints

Last updated: May 24, 2026

Montelukast sodium supply is dominated by large, vertically integrated generics and specialty-API manufacturers across India, China, and parts of Europe. Finished-dose market supply is concentrated among global branded and generic packagers, while API supply is broader and more fragmented, with multiple alternate synthesis routes and solid-form/process IP layers that can constrain short-notice substitution.

Who manufactures montelukast sodium API and where are the main suppliers?

Primary montelukast sodium API suppliers typically supply through commercial API manufacturers (India/China) to branded and generic finished-dose producers. The competitive landscape is characterized by:

• Multiple API sources meeting pharmacopeial specs
• Process-specific know-how that can be protected via patents and trade secrets
• Solid-form and polymorph controls that affect downstream formulation behavior and regulatory comparability

API supply hubs

Montelukast sodium API sourcing is most commonly traced to:

• India: strong presence of dosage-form and API contract manufacturing and generic API exporters.
• China: broad API manufacturing base with capacity for scale-up and cost-competitive supply.
• Europe: smaller number of API suppliers, more common for niche variants or internal use by formulation firms.

Typical supplier archetypes

• API-only specialty chemical manufacturers
• Contract API manufacturers supporting DMFs
• Finished-dose firms with dual API sourcing for cost control

Which companies supply montelukast sodium tablets and oral granules?

Finished-dose montelukast sodium supply is led by brand holders and large generic packagers. In practice, tablets and oral granules are commonly produced through:

• Contract manufacturing organizations (CMOs) with established US/EU regulatory track records
• Internal manufacturing for legacy brands and major generic portfolios
• Regional packagers that buy API and formulate locally for market access and logistics

Key finished-dose categories by product form

• Tablets (most common in major markets)
• Chewable tablets (market-specific formulation and excipient systems)
• Oral granules (often for pediatric dosing; formulation process controls are critical)
• Combination products (where applicable in some jurisdictions)

What are the common regulatory documents that define montelukast sodium supplier qualification?

For supplier selection, buyers typically anchor qualification on regulatory traceability:

• DMF (Drug Master File) references for the API and manufacturing controls
• CEP and supplier audit results for European submissions
• GMP inspections and site status reports
• Analytical package for polymorph/solid state controls, assay, impurities, and residual solvents

How buyers use DMF and GMP status

• API manufacturers with an active DMF listing allow finished-dose firms to reference the API manufacturing site in filings.
• GMP compliance history and remediation timelines determine “time-to-supply” during shortages or second-source procurement.

What patents or IP issues affect montelukast sodium supplier switching?

Supplier switching is constrained less by the molecule itself and more by what the buyer must preserve for regulatory continuity:

• Solid-state form controls (polymorphs, solvates, particle size distributions)
• Impurity profiles tied to synthesis route and purification strategy
• Process validation datasets needed for regulatory comparability
• Formulation-specific patents (for example, granule/tablet compositions, coating systems, or process parameters)

What can block alternate API entry

• Different impurity profiles or change in key intermediates can trigger additional analytical work.
• Solid-form variability can affect dissolution behavior, stability, and bioequivalence.

Which supplier regions are fastest for emergency allocation of montelukast sodium?

During shortages, procurement speed is typically highest from:

• Regions with dense manufacturing clusters (API and formulation)
• Suppliers with ready-to-ship inventory and pre-qualified DMF pathways
• Firms that already support multiple finished-dose customers and file harmonization for rapid tech transfer

India and China remain the highest-probability sourcing regions for near-term availability because they combine:

• Volume capacity
• Broad supplier redundancy
• Competitive lead times relative to smaller EU specialty producers

How do you assess quality and compliance across montelukast sodium suppliers?

Buyer diligence focuses on measurable controls, not marketing claims:

• Certificate-of-analysis (CoA) review: assay, water content, specific impurities, residual solvents
• Stability data alignment: forced degradation and real-time stability where relevant
• Particle size and distribution checks for formulation fit
• Batch traceability to the API manufacturing site and line
• GMP inspection outcomes for the manufacturing facility and sub-suppliers

Supplier scorecard metrics that drive procurement decisions

• Corrective and preventive action (CAPA) history
• Change control history for synthesis steps and purification units
• Time to deliver replacement CoA/spec revision
• Concordance of impurity profiles with prior reference lots

What finished-dose manufacturers commonly use multiple montelukast sodium API sources?

Large generic and branded producers typically qualify at least two API sources where feasible to reduce:

• Single-site disruption risk
• Transportation bottlenecks
• Regulatory delays during resubmission or variation filings

This multivendor approach is especially common for:

• High-velocity SKUs (tablets)
• Pediatric dosing presentations (oral granules) where consistency is tightly monitored

What is the typical procurement structure for montelukast sodium?

In practice, procurement breaks into:

• API supply contracts (price, specs, delivery schedules)
• Formulation and packaging arrangements (CMO or internal)
• Regulatory variation management (API change filings, stability commitments)

Where delays occur

• Analytical method transfer
• Spec harmonization and impurity controls
• Stability studies required for comparability after an API site change

How does montelukast sodium supplier selection affect cost and lead time?

Cost and lead time hinge on:

• Whether the supplier can ship inventory that already meets buyer specs
• Whether the API is already referenced in the buyer’s regulatory dossier framework
• Whether a new supplier requires additional validation runs and stability commitments

Commercial reality

• Lowest unit price is frequently offset by added validation and regulatory workload for a new supplier.
• “Fast switch” suppliers often price higher but reduce total program cost.

How strong are supply-chain/IP barriers when qualifying a new montelukast sodium API supplier?

Barriers are primarily operational:

• Solid-state and impurity profile comparability work
• CoA method alignment and analyst method validation
• Regulatory variation filings and stability bridge requirements

IP barriers can appear if:

• The API route is protected and supplier licensing is required
• The chosen synthesis route produces a different impurity signature that impacts comparability

What generic entry risks exist for montelukast sodium tied to supplier constraints?

Generic entry risk typically manifests as:

• Launch delay due to API scarcity or batch failures
• Restricted ability to scale because qualified API sources are limited
• Higher failure risk in process transfer for new manufacturing sites

Key Takeaways

• Montelukast sodium supply is sourced across India, China, and to a lesser extent Europe, with API manufacturing capacity broader than finished-dose packaging.
• Fastest substitution is usually achieved when the alternative API source is already referenced in DMF/regulatory frameworks and can match impurity and solid-state controls.
• Procurement decisions should be driven by GMP site status, CoA comparability, impurity and solid-form alignment, and prior dossier reference pathways.
• IP and regulatory continuity concerns are primarily operational (solid state, impurities, and comparability data), not structural barriers to the molecule.

FAQs

1. What CoA specs matter most when comparing montelukast sodium API from different suppliers?
2. How long does it typically take to qualify a new montelukast sodium API site for a registered finished-dose product?
3. What are the main solid-state and impurity risks when switching montelukast sodium manufacturers?
4. Do tablet and oral granule formulations of montelukast sodium require different API solid-form controls?
5. How do DMF references speed up montelukast sodium supplier changes for generic firms?

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References (APA)

1. FDA. (n.d.). Drug Master Files (DMFs). U.S. Food and Drug Administration.
2. EMA. (n.d.). European Medicines Agency: Certificates of Suitability (CEP) and quality documentation. European Medicines Agency.
3. USP. (n.d.). United States Pharmacopeia: Montelukast Sodium monograph. United States Pharmacopeia.