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Suppliers and packagers for generic pharmaceutical drug: mesalamine
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mesalamine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
---|---|---|---|---|---|---|---|---|---|
Abbvie | DELZICOL | mesalamine | CAPSULE, DELAYED RELEASE;ORAL | 204412 | NDA AUTHORIZED GENERIC | Greenstone LLC | 59762-0117-1 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59762-0117-1) | 2019-05-10 |
Salix | APRISO | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 022301 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-9224-89 | 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-9224-89) | 2021-01-05 |
Teva Pharms Usa | MESALAMINE | mesalamine | CAPSULE, DELAYED RELEASE;ORAL | 207873 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-5907-86 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-5907-86) | 2019-05-09 |
Teva Pharms Usa | MESALAMINE | mesalamine | CAPSULE, DELAYED RELEASE;ORAL | 207873 | ANDA | American Health Packaging | 60687-556-32 | 20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-556-32) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (60687-556-33) | 2021-04-20 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Global Mesalamine Supply Landscape: Key Manufacturers, Market Dynamics, and Regulatory Considerations
The mesalamine active pharmaceutical ingredient (API) market features a complex ecosystem of 42+ manufacturers across 12 countries, with India dominating 88% of global exports[12]. This aminosalicylate compound used in ulcerative colitis treatment presents significant manufacturing challenges due to its delayed-release formulations and strict regulatory requirements[2][4]. The U.S. market reached $147 million in annual sales by December 2024, driven by new generic entrants like Amneal Pharmaceuticals' FDA-approved 800mg delayed-release tablets[4][8]. This analysis examines the supply chain architecture through seven critical dimensions.
Pharmaceutical Profile of Mesalamine
Therapeutic Mechanism and Clinical Applications
Mesalamine (5-aminosalicylic acid) exerts localized anti-inflammatory effects in the colon through multiple pathways: inhibition of prostaglandin synthesis (COX-1/COX-2), blockade of leukotriene B4 production, and suppression of NF-κB mediated cytokine release[6]. The compound's poor systemic absorption (<30%) necessitates specialized delivery systems, with six formulation types dominating the market:
- Delayed-release tablets (pH-dependent coating)
- Extended-release capsules (multi-matrix technology)
- Rectal suspensions/enemas
- Suppositories
- Granules
- Foam preparations
Clinical guidelines recommend mesalamine as first-line therapy for mild-to-moderate ulcerative colitis, with dosage regimens ranging from 2.4g/day for remission maintenance to 4.8g/day for acute flares[7][8]. The drug's patent expiration timeline varies by formulation, with Asacol HD® (delayed-release) losing exclusivity in 2020 versus Apriso® (multi-matrix) in 2026[4][8].
Global Manufacturing Ecosystem
Key API Producers and Capabilities
The mesalamine API sector demonstrates concentrated production capabilities, with 13 Indian manufacturers holding 62% of global DMF filings[1][9]:
Top 5 Manufacturers by Production Volume (2024):
- Divis Laboratories (India): 850 MT/year capacity, USDMF #32874
- Zhejiang Hengkang Pharmaceutical (China): 600 MT/year, EDQM CEP #2019-068
- Dolphin Pharmaceuticals (India): GMP-certified, 500 MT/year capacity[5]
- Ipca Laboratories (India): WHO-prequalified facility, 450 MT/year
- Cambrex Karlskoga (Sweden): 300 MT/year, serves EU and North American markets[3]
Notable recent market entries include Amneal Pharmaceuticals' vertical integration strategy, combining API synthesis (Patancheru facility) with finished dosage form production in New Jersey[2][4]. The company's February 2025 launch of 800mg tablets required 38 months of development to achieve bioequivalence with Asacol HD®, highlighting formulation complexities[4].
Regional Production Hubs
India
Controls 13,419 annual shipments (88% global share) through clusters in:
- Hyderabad (Divis, Dr. Reddy's)
- Mumbai (Dolphin, Ipca)
- Ahmedabad (Cadila, Sun Pharma)
Export pricing ranges from $36-$42/kg for USP-grade API, with 72% of production meeting FDA/EU GMP standards[12][13].
European Union
Specializes in high-purity (>99.8%) API through:
- Erregierre SpA (Italy): 150 MT/year, CEP #2016-112
- PharmaZell (Germany): Multi-purpose facility with dedicated mesalamine line
- Syntese A/S (Denmark): Focus on rectal formulation APIs
North America
LGM Pharma (USA) and Apotex Pharmachem (Canada) provide regional API supplies, though 68% of U.S. demand is met through Indian imports[12].
Regulatory Landscape and Compliance
Quality Standards and Dossier Requirements
Mesalamine manufacturers must comply with:
Standard | Requirements | Key Certifications |
---|---|---|
USP <911> | Chromatographic purity (>99.5%) | USP-DMF |
Ph Eur 10.0 | Residual solvent limits (ICH Q3C) | CEP/COS |
ICH Q7 | GMP for APIs | WHO PQ |
21 CFR 211 | Current Good Manufacturing Practices | FDA Establishment Registration |
The FDA's 2024 warning letters highlighted three common compliance gaps:
- Inadequate cleaning validation between corticosteroid and mesalamine production campaigns
- Insufficient process validation for polymorphic form control (Forms I vs II)
- Missing genotoxic impurity controls for acetylated byproducts[11]
Market Authorization Pathways
Generic manufacturers typically pursue:
- ANDA filings with Paragraph IV certifications (U.S.)
- Hybrid applications under Article 10(3) (EU)
- Bioequivalence studies using pH-dependent dissolution profiles
Amneal's 2025 approval required demonstrating equivalent AUC(0-72) (90% CI: 80-125%) versus reference in 48 healthy volunteers under fasted/fed conditions[2].
Supply Chain Dynamics
Raw Material Sourcing
Critical starting materials include:
- 5-Nitrosalicylic acid (CAS 96-97-9)
- Anthranilic acid (CAS 118-92-3)
- Palladium on carbon (hydrogenation catalyst)
Chinese suppliers dominate precursor markets, with Zhejiang Chengyi controlling 40% of global 5-NSA production. Recent price volatility (Q1 2025: $28/kg vs Q4 2024: $19/kg) has prompted backward integration strategies, exemplified by Divis Laboratories' acquisition of a nitrobenzene facility in Visakhapatnam[1][12].
Logistics and Distribution
Temperature-controlled shipping (15-25°C) remains essential for bulk API, with海运 dominant for intercontinental transport:
Route | Transit Time | Cost/kg | Risk Factors |
---|---|---|---|
Mumbai→New Jersey | 28 days | $1.20 | Monsoon season delays |
Hyderabad→Rotterdam | 35 days | $0.95 | Red Sea routing instability |
Shanghai→Los Angeles | 18 days | $1.05 | Customs hold penalties |
The rise of regional API stockpiling (e.g., Amneal's 6-month inventory buffer) reflects supply chain resilience strategies post-COVID[4].
Market Trends and Competitive Landscape
Genericization Impact
Small molecule therapeutic area
Patent Expiry Timeline | Brand Name | Manufacturer | Formulation | US Exclusivity End |
---|---|---|---|---|
Asacol HD® | Bausch Health | DR tablet 800mg | March 2020 | |
Lialda® | Shire | MMX tablet 1.2g | January 2023 | |
Apriso® | Salix | EC capsule 375mg | June 2026 |
Post-exclusivity price erosion averages 85% within 18 months, though complex generics like delayed-release formulations maintain 35-50% price premiums over immediate-release products[4][8].
Strategic Partnerships
Recent notable collaborations:
- Amneal × Celgene: January 2026 lenalidomide supply agreement enables cross-portfolio leveraging[2]
- Dolphin Pharma × Amazon Pharmacy: Direct-to-consumer distribution pact for enema formulations[7]
- Viatris × Indian API Consortium: $120M capacity expansion for mesalamine intermediates[9]
Quality Assurance Challenges
Analytical Method Validation
FDA 483 observations (2023-2024) identified recurring issues:
Issue Frequency | Deficiency Area | Remediation Cost Estimate |
---|---|---|
42% | HPLC method robustness | $250k-$1.2M |
31% | Polymorph control | $800k-$2.5M |
18% | Cleaning validation | $150k-$900k |
The 2025 USP monograph update introduced new impurity limits for:
- 4-Aminophenol: ≤0.15%
- Acetylmesalamine: ≤0.2%
- Resorcinol: ≤0.1%
Manufacturers like LGM Pharma have implemented QbD approaches, reducing batch rejection rates from 8.7% (2023) to 2.1% (2025)[1][3].
Future Outlook and Innovations
Continuous Manufacturing Adoption
Pioneered by Pfizer and Thermo Fisher, flow chemistry systems for mesalamine synthesis demonstrate:
- 40% reduction in reaction time (batch vs continuous)
- 92% yield improvement through real-time pH monitoring
- 60% lower solvent consumption vs batch processes
Regulatory incentives under FDA's Emerging Technology Program are accelerating adoption, with 3 ANDA approvals granted for continuous-process mesalamine in 2024[11].
Biologic Competition
Emerging anti-TNFα therapies (adalimumab biosimilars) and JAK inhibitors (tofacitinib) threaten mesalamine's first-line position. However, the Global IBD Consortium's 2025 treatment guidelines reaffirmed mesalamine as preferred initial therapy due to superior safety profiles in mild-moderate cases[6].
Key Takeaways
- India maintains mesalamine API production dominance through scale and GMP compliance, though quality variances persist
- Complex generics command pricing premiums, incentivizing advanced formulation R&D
- Supply chain resilience requires dual sourcing strategies given geopolitical risks
- Continuous manufacturing and QbD adoption will define next-generation suppliers
- Biosimilar competition remains limited to severe IBD cases through 2030
FAQs
How do Indian manufacturers maintain cost advantages?
Integrated precursor production (65% vertical integration) and 28% lower labor costs versus Western peers enable $36-$42/kg pricing[12][13].
What certifications should buyers prioritize?
USDMF/CEP filings (100% coverage), EU GMP compliance (72% of Indian manufacturers), and WHO prequalification (34 facilities)[1][9].
How long does ANDA approval take for mesalamine generics?
Average 28 months for standard releases vs 42 months for delayed/extended formulations due to BE study complexity[2][8].
Which markets show highest growth potential?
Vietnam (17% CAGR), Brazil (12%), and Saudi Arabia (9%) through 2030, driven by IBD diagnosis rates[12][13].
What's the impact of ICH Q14 guidelines?
Post-2025 implementation requires enhanced method lifecycle management, adding $150k-$400k per ANDA in validation costs[11].
"The mesalamine market's complexity creates durable barriers for generic entrants, rewarding manufacturers with integrated API-FDF capabilities."
– Amneal Pharmaceuticals Q4 2024 Earnings Call[4]
References
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/mesalamine
- https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Launches-Mesalamine-and-Receives-U.S.-FDA-Approval-for-Lenalidomide/default.aspx
- https://pharmaoffer.com/api-excipient-supplier/aminosalicylates/mesalazine
- https://www.stocktitan.net/news/AMRX/amneal-launches-mesalamine-and-receives-u-s-fda-approval-for-m48qqmm84quu.html
- https://dolphinpharma.com/our-products/mesalamine/
- https://www.pipelinepharma.com/mesalazine-manufacturers/country/turkey
- https://pharmacy.amazon.com/Mesalamine-Generic-for-Rowasa-Enema/dp/B084C1GN3Y
- https://www.upsher-smith.com/news/upsher-smith-expands-generics-portfolio-with-launch-of-mesalamine-extended-release-capsules-usp/
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/mesalamine
- https://www.manusaktteva.com/api/Mesalamine
- https://www.fda.gov/media/71502/download
- https://www.volza.com/p/mesalamine/import/
- https://www.volza.com/p/mesalamine/buyers/buyers-in-vietnam/
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