Etoricoxib API

Etoricoxib is a synthetic selective cyclooxygenase‑2 (COX‑2) inhibitor active pharmaceutical ingredient (API). It belongs to the coxib subgroup of non‑steroidal anti‑inflammatory drugs (NSAIDs). It demonstrates high selectivity towards COX‑2 over COX‑1 enzyme. This raw material is widely adopted by pharmaceutical manufacturers, CRO labs and research institutes for oral solid dosage form development, generic registration batches, preclinical mechanism research and analytical QC validation. We supply GMP-grade powder with consistent crystal form, tight impurity control and complete regulatory documentation packages to support ANDA, DMF and local drug registration projects worldwide.

1.Film-coated tablet formulation & generic drug manufacturing

Etoricoxib API is the core active raw material for the development and commercial production of oral film-coated tablets. Formulation teams carry out powder blending, granulation, tableting and coating process development. Multiple strength specifications (30mg, 60mg, 90mg, 120mg) can be developed according to pharmacopoeia requirements. It is used for generic solid oral dosage form projects of selective COX-2 inhibitor products.

2.Preclinical pharmacology & COX‑2 enzyme mechanism research

Supplied to university labs, CRO and pharmacological research institutions as a reference compound for COX‑2 / COX‑1 selectivity studies, prostaglandin pathway research, anti-inflammatory and analgesic mechanism evaluation, in-vivo PK/PD modelling and comparative screening with other coxib APIs.

3.Analytical method validation & QC laboratory testing

Qualified Etoricoxib powder can be used as working reference standard for pharmaceutical QC labs. It supports HPLC method validation, system suitability, impurity quantification, LOQ/LOD verification and routine incoming raw material inspection aligned with USP and EP standards.

4.Bioequivalence (BE) batches & registration stability studies

Bulk Etoricoxib API is supplied for registration stability batches, accelerated stability testing and BE clinical trial batches for generic drug applicants. Batch release data, impurity trend and stability reports can be provided to support regulatory dossiers submission in different regions.

1.High purity Etoricoxib crystalline powder with stable Form I polymorph, consistent batch-to-batch performance for tablet compression.

2.Superior COX‑2 selectivity profile, well‑characterized impurity profile complying with USP & EP monograph limits.

3.Good powder flow property and formulation compatibility, suitable for film-coated tablet manufacturing.

4.Long plasma half-life supports once-daily dosing formulation design for generic developers.

5.Flexible MOQ: small trial batches for lab R&D, registration batches and commercial bulk supply available.

6.Full document package including COA, TDS, SDS, heavy metals, residual solvent reports to simplify drug registration submission.

This adverse reaction summary is for pharmaceutical formulation, preclinical and dossier reference only. It is NOT medical advice for patients. Final prescribing information shall follow the official monograph and local regulatory package insert.

Etoricoxib is a selective COX‑2 inhibitor NSAID. The adverse event profile is compiled based on published clinical literature and official drug labeling, for R&D team reference during formulation development, risk assessment and registration dossier preparation.

Common reported adverse reactions in clinical studies:

Gastrointestinal: abdominal discomfort, nausea, dyspepsia, diarrhea

Nervous system: headache, dizziness

Cardiovascular: peripheral edema, elevated blood pressure; higher risk with long-term high-dose use in susceptible populations

Hepatic: transient mild liver enzyme elevation

Other: fatigue, rash, pruritus

Serious adverse events (rare):

Serious cardiovascular thrombotic events (myocardial infarction, stroke)

Severe gastrointestinal ulceration or bleeding

Hypersensitivity reactions including anaphylaxis

Severe skin adverse reactions

Renal function impairment, fluid retention

Contraindication reference for formulation risk evaluation:

Patients with ischemic heart disease, cerebrovascular disease, congestive heart failure

Active peptic ulcer, gastrointestinal bleeding

Severe hepatic or renal impairment

Hypersensitivity to etoricoxib or coxib-class drugs

1.Packing form: Aluminum foil bag for small samples; 25kg fiber drum with inner PE bag for bulk

2.Storage requirement: Cool, dry, sealed, avoid moisture and direct sunlight

3.Shelf life: 24 months under proper sealed storage

We supply GMP grade Etoricoxib API for pharmaceutical manufacturers, CRO laboratories, R&D institutes and generic registration projects worldwide. You can place your inquiry through our website:

1.Inquiry methods：
Email:alice@xaheshun.com
Whatspp:+8618509260106

Online instant messaging

2.Contact Information：
Name：Alice

Telephone :+8618509260106
Email:alice@xaheshun.com

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