You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 28, 2025

Suppliers and packagers for generic pharmaceutical drug: mesalamine


✉ Email this page to a colleague

« Back to Dashboard


mesalamine

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

ApplicantTradenameGeneric NameDosageNDANDA/ANDASupplierPackage CodePackageMarketing 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
Showing 1 to 4 of 4 entries

Global Mesalamine Supply Landscape: Key Manufacturers, Market Dynamics, and Regulatory Considerations

Last updated: July 27, 2025

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:

  1. Delayed-release tablets (pH-dependent coating)
  2. Extended-release capsules (multi-matrix technology)
  3. Rectal suspensions/enemas
  4. Suppositories
  5. Granules
  6. 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):

  1. Divis Laboratories (India): 850 MT/year capacity, USDMF #32874
  2. Zhejiang Hengkang Pharmaceutical (China): 600 MT/year, EDQM CEP #2019-068
  3. Dolphin Pharmaceuticals (India): GMP-certified, 500 MT/year capacity[5]
  4. Ipca Laboratories (India): WHO-prequalified facility, 450 MT/year
  5. 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:

  1. Inadequate cleaning validation between corticosteroid and mesalamine production campaigns
  2. Insufficient process validation for polymorphic form control (Forms I vs II)
  3. Missing genotoxic impurity controls for acetylated byproducts[11]

Market Authorization Pathways

Generic manufacturers typically pursue:

  1. ANDA filings with Paragraph IV certifications (U.S.)
  2. Hybrid applications under Article 10(3) (EU)
  3. 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:

  1. Amneal × Celgene: January 2026 lenalidomide supply agreement enables cross-portfolio leveraging[2]
  2. Dolphin Pharma × Amazon Pharmacy: Direct-to-consumer distribution pact for enema formulations[7]
  3. 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

  1. India maintains mesalamine API production dominance through scale and GMP compliance, though quality variances persist
  2. Complex generics command pricing premiums, incentivizing advanced formulation R&D
  3. Supply chain resilience requires dual sourcing strategies given geopolitical risks
  4. Continuous manufacturing and QbD adoption will define next-generation suppliers
  5. 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

  1. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/mesalamine
  2. https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Launches-Mesalamine-and-Receives-U.S.-FDA-Approval-for-Lenalidomide/default.aspx
  3. https://pharmaoffer.com/api-excipient-supplier/aminosalicylates/mesalazine
  4. https://www.stocktitan.net/news/AMRX/amneal-launches-mesalamine-and-receives-u-s-fda-approval-for-m48qqmm84quu.html
  5. https://dolphinpharma.com/our-products/mesalamine/
  6. https://www.pipelinepharma.com/mesalazine-manufacturers/country/turkey
  7. https://pharmacy.amazon.com/Mesalamine-Generic-for-Rowasa-Enema/dp/B084C1GN3Y
  8. https://www.upsher-smith.com/news/upsher-smith-expands-generics-portfolio-with-launch-of-mesalamine-extended-release-capsules-usp/
  9. https://www.pharmacompass.com/manufacturers-suppliers-exporters/mesalamine
  10. https://www.manusaktteva.com/api/Mesalamine
  11. https://www.fda.gov/media/71502/download
  12. https://www.volza.com/p/mesalamine/import/
  13. https://www.volza.com/p/mesalamine/buyers/buyers-in-vietnam/

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.