Share This Page
Suppliers and packagers for generic pharmaceutical drug: MELOXICAM; RIZATRIPTAN BENZOATE
✉ Email this page to a colleague
MELOXICAM; RIZATRIPTAN BENZOATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Axsome | SYMBRAVO | meloxicam; rizatriptan benzoate | TABLET;ORAL | 215431 | NDA | Axsome Therapeutics, Inc. | 81968-020-02 | 1 BOTTLE in 1 CARTON (81968-020-02) / 2 TABLET in 1 BOTTLE | 2025-05-19 |
| Axsome | SYMBRAVO | meloxicam; rizatriptan benzoate | TABLET;ORAL | 215431 | NDA | Axsome Therapeutics, Inc. | 81968-020-03 | 1 BOTTLE in 1 CARTON (81968-020-03) / 3 TABLET in 1 BOTTLE | 2025-05-19 |
| Axsome | SYMBRAVO | meloxicam; rizatriptan benzoate | TABLET;ORAL | 215431 | NDA | Axsome Therapeutics, Inc. | 81968-020-09 | 9 TABLET in 1 BOTTLE (81968-020-09) | 2025-05-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: MELOXICAM; RIZATRIPTAN BENZOATE
Meloxicam and Rizatriptan Benzoate API and Finished-Dosage Suppliers: Who Supplies the Market and What to Source
Meloxicam and rizatriptan benzoate are widely manufactured with multiple qualified API and generic finished-dosage suppliers across the US/EU/Asia. The supplier landscape is split into (1) API makers (active pharmaceutical ingredient), (2) finished-dose manufacturers (tablets, capsules, ODT, etc.), and (3) contract manufacturing organizations (CMOs) supporting dosage-form development and scale-up.
What follows are supplier categories and the key sourcing targets buyers use to secure compliant supply chains for meloxicam and rizatriptan benzoate.
Who supplies meloxicam API to generic and brand manufacturers?
Meloxicam is commonly sourced as API for generic tablet manufacture, with the market dominated by large Asian API suppliers plus select European distributors. Buyers typically qualify suppliers under GMP and trace documentation (DMF/CEP where applicable), then lock supply via long-term agreements or multi-sourcing.
What types of suppliers provide meloxicam API?
- API manufacturers (primary): Produce meloxicam API under GMP with regulatory support (DMF and/or CEP depending on jurisdiction).
- API distributors/traders (secondary): Source from primary manufacturers and supply to US/EU finished-dose makers.
- CMOs for finished tablets: Buy API and formulate/compress tablets under contract.
Where do buyers typically source meloxicam from?
- China and India: Largest concentration of API manufacturing capacity.
- Europe: Smaller number of API producers; more emphasis on distribution and finished-dose manufacturing.
Which companies supply meloxicam tablets and what dosage forms are covered?
Meloxicam is most frequently marketed as tablets in multiple strengths. Supplier selection depends on dosage-form requirements, including dissolution behavior, tablet hardness, and excipient compatibility.
Common meloxicam finished-dose formats
- Immediate-release tablets (most common)
- Strength variants (commonly 7.5 mg and 15 mg in many markets)
- Combination products are less common than monotherapy
Finished-dose supplier profile
- Generic tablet manufacturers with Abbreviated New Drug Application (ANDA) track records
- CMOs with regulatory-ready equipment and in-house analytical methods for assay, dissolution, and impurities
Who supplies rizatriptan benzoate API for oral solid products?
Rizatriptan benzoate API is used for generic and branded oral solid migraine therapies. Like meloxicam, the sourcing model uses API qualification plus finished-dose manufacturing.
Rizatriptan benzoate supplier categories
- API manufacturers: Provide the active material with GMP documentation for global markets.
- API intermediaries and distributors: Support distribution to finished-dose manufacturers.
- CMOs and contract packagers: Support formulation, tableting, and packaging requirements.
Which companies supply rizatriptan benzoate tablets and what formulation constraints matter?
Rizatriptan benzoate oral solid products require tight control over impurity profiles, dissolution, and stability. Supplier qualification often includes:
- Impurity specification alignment with regulatory filings
- Stability testing and packaging compatibility
- Consistent polymorphic form control where relevant
Common rizatriptan benzoate dosage formats
- Tablets (most common in generic portfolios)
- Strength variants by market and label
How do API and finished-dose suppliers differ for meloxicam vs rizatriptan benzoate?
Supply-chain differences that affect sourcing
- Meloxicam: High-volume, mature generic market. Buyers often optimize for price and reliable tablet compression capability.
- Rizatriptan benzoate: Smaller molecule in migraine category with fewer high-volume supply chains in some regions. Buyers often optimize for impurity control, stability, and consistent dissolution performance.
Commercial procurement impact
- Meloxicam typically tolerates broader multi-sourcing and common tablet manufacturing platforms.
- Rizatriptan benzoate more often requires supplier assurance on analytical method transfer and lot-to-lot impurity consistency.
What contract manufacturing (CMO) capabilities do buyers need for these products?
Core CMO capabilities buyers require
- GMP solid oral manufacturing (compression, blending, granulation if needed)
- Validation packages aligned to ANDA submissions
- Analytical testing: HPLC assay, impurity profiling, dissolution, stability
- Packaging line capability (bottles/blisters) and labeling support
Technical constraints that drive CMO selection
- Dissolution matching and robustness during scale-up
- Excipient compatibility for API stability
- Impurity control strategy for each API supplier’s impurity profile
How to structure a compliant supplier program for meloxicam and rizatriptan benzoate?
Typical supplier qualification checklist
- GMP compliance evidence for API and finished dose
- Regulatory dossier support (DMF/CEP where used)
- Quality agreement terms: change control, notification timelines, deviation handling
- Audit readiness and continuous monitoring
- Traceability from API to finished lots
Multi-sourcing strategy
- Qualify at least two API sources for continuity
- Qualify at least two finished-dose manufacturing sites where volumes justify redundancy
- Lock API supply with clear acceptance criteria at the finished-dose stage
Key Takeaways
- Meloxicam and rizatriptan benzoate are supplied through multi-tier chains: API makers, API distributors, and GMP finished-dose manufacturers/CMOs.
- Meloxicam has a broad, mature generic supply base with heavy emphasis on tablet manufacturing cost and throughput.
- Rizatriptan benzoate sourcing places higher weight on impurity consistency and formulation stability for oral solids.
- A compliant procurement program hinges on GMP evidence, regulatory dossier support, quality agreements, and change-control governance.
- Buyers should multi-source API and finished-dose manufacturing to manage supply disruption and pricing volatility.
FAQs
1) What documents do buyers ask for when qualifying meloxicam API suppliers?
GMP compliance documentation, impurity specification control, batch analysis trends, and regulatory dossier support aligned with intended markets.
2) What quality agreements matter most for rizatriptan benzoate API supply?
Change control terms, out-of-specification handling, deviation notification timelines, and bridging study requirements for process or supplier changes.
3) Can a CMO switch API sources for meloxicam without affecting product performance?
It depends on bridging requirements for dissolution/impurity profiles and compatibility with the approved formulation and manufacturing process.
4) How do buyers reduce risk in rizatriptan benzoate finished-dose manufacturing?
Multi-source qualification, tighter in-process controls, and stability-driven packaging and shelf-life verification.
5) What should be prioritized in audits for both APIs and finished-dose sites?
GMP training, deviation/CAPA effectiveness, analytical method validation, stability program integrity, and documentation completeness from receipt to release.
References
No sources were provided in the prompt, and none are cited here.
More… ↓
