Piroxicam API Manufacturer in India

Molecular Formula

C15H13N3O4S

Molecular Weight

331.35 g/mol

CAS Number

36322-90-4

Drug Class

NSAID

NSAID API for anti-inflammatory and analgesic formulations.

Key Product Information

Generic Name Piroxicam
CAS Number 36322-90-4
Molecular Formula C15H13N3O4S
Molecular Weight 331.35 g/mol
Drug Class NSAID (Non-Steroidal Anti-Inflammatory Drug)
Dosage Form Suitability Capsules, Topical Gel, Suppositories, Tablets
Use Case Anti Inflammatory
Primary Application Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis, Musculoskeletal Pain
Production Capacity 10 MT/Month
Grade
IP BP USP EP
Regulatory Documentation COA, DMF available on request

Applications & Use Cases

NSAID / Analgesic — these are used for pain relief and to reduce inflammation. Piroxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) used to treat pain and stiffness from conditions like arthritis. Manufactured meeting compendial tests for identity, assay, and related substances, packaged for bulk export from Gujarat, India.

Kodel Life manufactures Piroxicam API (CAS 36322-90-4) to IP, BP, USP, and EP pharmacopoeial standards from its ISO 9001:2015 certified facility in Morbi, Gujarat, India. This high-purity NSAID active pharmaceutical ingredient is purpose-built for anti-inflammatory and analgesic formulations across four dosage forms: capsules, topical gel, suppositories, and tablets.

With 10 MT per month production capacity and complete regulatory documentation, Kodel Life is a trusted Piroxicam API bulk supplier and pharmaceutical manufacturer serving buyers across 21 countries.

Request COA & DMF Today ISO 9001:2015 Certified Ships to 21 Countries

Piroxicam API: Product Specifications

Parameter Details
Generic Name Piroxicam
CAS Number 36322-90-4
Molecular Formula C15H13N3O4S
Molecular Weight 331.35 g/mol
IUPAC Name 4-hydroxy-2-methyl-N-(pyridin-2-yl)-2H-1,2-benzothiazine-3-carboxamide 1,1-dioxide
Drug Class NSAID (Non-Steroidal Anti-Inflammatory Drug)
Pharmacopoeial Grade IP / BP / USP / EP
Production Capacity 10 MT per Month
Dosage Form Suitability Capsules, Topical Gel, Suppositories, Tablets
Primary Application Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis, Musculoskeletal Pain
Regulatory Docs COA and DMF available on request

What Is Piroxicam API?

Piroxicam is a long-acting, non-selective cyclooxygenase (COX) inhibitor belonging to the oxicam class of NSAIDs. It blocks prostaglandin biosynthesis through inhibition of both COX-1 and COX-2 enzymes, producing anti-inflammatory, analgesic, and antipyretic effects. Its plasma half-life of approximately 50 hours allows once-daily dosing, which sets it apart from shorter-acting NSAIDs and makes it particularly useful in managing chronic inflammatory conditions such as rheumatoid arthritis and osteoarthritis.

As an Active Pharmaceutical Ingredient, Piroxicam must meet stringent identity, assay, related substance, and particle size specifications across all four target pharmacopoeias. Kodel Life manufactures to IP, BP, USP, and EP monograph standards in a single cGMP-compliant facility, giving pharmaceutical buyers a batch-verified, fully documented starting material regardless of their target market.

Key Takeaway

Piroxicam's 50-hour half-life enables once-daily dosing in both oral and rectal dosage forms. This single-dose convenience is a formulation advantage that differentiates Piroxicam from most short-acting NSAIDs in the chronic pain and arthritis segment.

Piroxicam API for Multiple Dosage Form Formulations

Piroxicam is one of the most formulation-versatile NSAIDs in the generic pharmaceutical market. It is produced in four distinct dosage forms, each requiring specific API particle size, purity, and stability characteristics. Kodel Life supplies Piroxicam API with grade specifications and particle size data matched to each formulation pathway.

Oral Capsule Formulation (10 mg, 20 mg)

Hard gelatin capsules represent the dominant global Piroxicam formulation. API for direct capsule filling or granule encapsulation must meet consistent particle size and flow specifications.

Controlled PSD for reliable capsule fill weight and content uniformity

Polymorphic Form I stability confirmed throughout shelf life for dissolution consistency

Low moisture content compatible with direct-fill and wet granulation capsule processes

Assay of 99.0% or above per IP and USP monograph specifications

Topical Gel and Cream Formulation (0.5%)

Piroxicam 0.5% topical gel is widely prescribed across Asia, Europe, and the Middle East for localised musculoskeletal pain. Micronised API with a fine PSD is required for homogeneous dispersion in gel bases.

Micronised particle size for uniform dispersion in polyethylene glycol and carbomer gel bases

Extremely low related substance profile to minimise the risk of skin irritation

Solubility profile compatible with standard semi-solid excipients

Photostability data available to support photosensitivity risk labelling decisions

Suppository Formulation (20 mg)

Piroxicam suppositories are used when oral administration is not clinically appropriate, including post-surgical pain management and chronic arthritis flares.

Compatibility data available for Witepsol and cocoa butter suppository bases

Documented melting point behaviour for suppository mass temperature sensitivity

Batch records confirming in-vitro dissolution performance within the suppository matrix

Tablet Formulation (10 mg, 20 mg, Dispersible)

Conventional and dispersible Piroxicam tablets are produced across several regulated and emerging markets. Direct compression and wet granulation processes each have distinct API requirements.

Defined PSD for wet granulation tabletting compatibility

Flowability characteristics suitable for direct compression formulations

Stability data available to support 24- and 36-month shelf life claims on compressed dosage forms

Formulators receive a dosage form-specific Technical Data Package on request. This includes the COA, full impurity profile, method validation data, polymorphic form confirmation, and stability data matched to their target dosage form.

Kodel Life as a Piroxicam API Manufacturing Company

Kodel Life is a dedicated pharmaceutical API manufacturing company based in Morbi, Gujarat, India. The facility is ISO 9001:2015 certified and operates under FDA-compliant cGMP standards, producing NSAID, cardiovascular, and diuretic APIs at commercial scale for pharmaceutical buyers across 21 countries.

Quality and Analytical Capabilities

ISO 9001:2015 certified facility in Morbi, Gujarat, India

FDA-compliant cGMP manufacturing across all active API products

In-house analytical laboratory covering HPLC, IR identity, assay, related substances, PSD, and moisture

Compendial testing to IP, BP, USP, and EP pharmacopoeial monograph specifications

Batch-specific COA issued with every shipment; DMF documentation available for all commercial APIs

ICH Q3A-compliant impurity profiling and ICH Q1A stability data available on request

Multi-Product Portfolio: One Qualified Supplier for Your Full API Requirement

Kodel Life is not a single-molecule manufacturer. The same ISO-certified facility produces a full portfolio of cardiovascular and diuretic APIs, enabling pharmaceutical buyers to consolidate vendor qualifications and reduce regulatory audit overhead.

API Product Capacity Drug Class Supplier Role
Furosemide API 20 MT/Month Loop Diuretic Furosemide API manufacturing company — IP/BP/USP/EP grade, bulk export from India
Metoprolol Succinate API 20 MT/Month Beta Blocker (ER) Metoprolol Succinate API manufacturing company — once-daily ER tablet grade supply
Metoprolol Tartrate API 62 MT/Month Beta Blocker (IR) Metoprolol Tartrate API manufacturing company — IR tablet and IV injectable grade supply
Hydrochlorothiazide API 10 MT/Month Thiazide Diuretic IP/BP/USP/EP grade — antihypertensive and combination formulation supply
Piroxicam API 10 MT/Month NSAID This page — capsule, topical gel, suppository, and tablet grade supply

Qualifying one API supplier for cardiovascular, diuretic, and NSAID APIs reduces audit cycles, simplifies documentation management, and streamlines procurement. Kodel Life provides a single regulatory dossier framework across all five APIs.

View the Full API Portfolio

Piroxicam API Bulk Supply and Export from India

Kodel Life is an established Piroxicam API bulk supplier from India, with active export relationships across 21 countries on five continents. Bulk supply is available from development-scale samples through to commercial orders of up to 10 MT per month.

Export Markets

Southeast Asia

Thailand, Vietnam, Myanmar, Malaysia, Philippines

South Asia

Sri Lanka, Bangladesh, Nepal, Pakistan

Middle East

UAE, Saudi Arabia, Jordan

Africa

Kenya, Tanzania, Nigeria, Ethiopia, South Africa

Europe and CIS

Germany, Russia, Ukraine

Americas

USA, Brazil, Canada

What Every Bulk Shipment Includes

Batch-specific Certificate of Analysis (COA) to the specified pharmacopoeial standard

Drug Master File (DMF) reference letter or open DMF support for regulatory submissions

Stability data per ICH Q1A: six-month accelerated and 12-month long-term results

Impurity profile per ICH Q3A: identification and qualification thresholds met

Shipping and customs documentation for destination market import compliance

Material Safety Data Sheet (MSDS/SDS) for hazardous material handling compliance

Bulk Supply Lead Time

Development samples are dispatched within one to two business days of confirmed request. Commercial bulk orders are supported with dedicated export documentation and a regulatory affairs liaison. Contact the team via the enquiry form or WhatsApp (+91 75023 33335) to discuss specific quantities and lead times.

Regulatory Documentation for Global Markets

Piroxicam API supplied into regulated markets, including the EU, US, Canada, Japan, and Australia, requires a complete regulatory dossier beyond the Certificate of Analysis. Kodel Life provides the full documentation stack as standard.

Certificate of Analysis (COA) per batch: IP, BP, USP, or EP monograph as specified by the buyer

Drug Master File (DMF) support: Type II DMF filing for US submissions; ASMF for EU CTD submissions

Impurity profiles per ICH Q3A: all related substances identified and qualified

Residual solvent data per ICH Q3C: Class 2 and Class 3 solvents profiled per batch

Stability data per ICH Q1A: accelerated (40°C/75% RH) and long-term (25°C/60% RH) conditions

Method validation certificates per ICH Q2R1

Polymorphic form confirmation and particle size distribution reports

Regulatory affairs teams working on EU CTD or US ANDA submissions can request an open or closed DMF reference letter. Buyers in ASEAN markets receive COA plus country-specific import compliance support from the Kodel Life export documentation team.

Piroxicam vs Meloxicam: Choosing the Right NSAID API

Piroxicam and Meloxicam are both oxicam-class NSAIDs. Pharmaceutical procurement teams frequently evaluate both when building or expanding an NSAID API portfolio. The comparison below covers the key decision factors.

Parameter Piroxicam (CAS 36322-90-4) Meloxicam (CAS 71125-38-7)
COX Selectivity Non-selective (COX-1 and COX-2) Preferentially COX-2 selective
Plasma Half-Life ~50 hours (once-daily dosing) ~20 hours (once-daily dosing)
Primary Dosage Forms Capsules, topical gel, suppositories, tablets Tablets, oral suspension, injectable
Approved Indications RA, OA, Ankylosing Spondylitis, musculoskeletal pain RA, OA, juvenile idiopathic arthritis
Typical Daily Dose 10-20 mg 7.5-15 mg
GI Risk Profile Higher GI risk (COX-1 inhibition) Lower GI risk (COX-2 preference)
Photosensitivity Documented photosensitivity reported Lower photosensitivity risk
Market Positioning Established off-patent generic, OTC in some markets Premium generic in musculoskeletal segment
Kodel Life Supply Yes: IP/BP/USP/EP, 10 MT/Month Intermediate available (Meloxicam/Piroxicam Intermediate)

Kodel Life also supplies the Meloxicam/Piroxicam Intermediate, the shared chemical precursor for both API synthesis pathways. Manufacturers producing both NSAIDs can source the intermediate from the same qualified supplier, reducing vendor qualification overhead.

Where Piroxicam API Is Used

Piroxicam API is sourced by generic pharmaceutical companies, NSAID-focused contract development and manufacturing organisations (CDMOs), branded generics manufacturers, and OTC product developers. Common applications include:

Hard gelatin capsules (10 mg, 20 mg) for rheumatoid arthritis and osteoarthritis management

Topical gel (0.5%) for localised musculoskeletal, joint, and soft tissue pain

Suppositories (20 mg) for post-surgical and chronic pain management where oral dosing is not appropriate

Dispersible and standard tablets for paediatric and geriatric anti-inflammatory treatment

Combination NSAID formulations with antacid or gastroprotective co-formulation ingredients

OTC analgesic and anti-inflammatory products in markets where Piroxicam holds OTC approval

Veterinary anti-inflammatory formulations, including use in veterinary oncology protocols

How to Order Piroxicam API from Kodel Life

Kodel Life serves pharmaceutical buyers from early development through commercial bulk supply. The process runs in five steps:

1

Submit an enquiry via the contact form or WhatsApp (+91 75023 33335). Specify your target dosage form and pharmacopoeial standard.

2

Receive the COA, full specification sheet, and pricing within one to two business days.

3

Request a development sample or dosage form-specific Technical Data Package for in-house testing and formulation work.

4

Confirm order quantity, packaging specification, and export documentation requirements.

5

Shipment dispatched with the complete documentation package: COA, DMF reference letter, stability data, and SDS.

Ready to Source Piroxicam API from India?

Kodel Life works with generic pharmaceutical companies, CDMOs, branded generics manufacturers, and trading houses sourcing NSAID APIs from India. Whether you need a development sample, a full regulatory dossier, or a long-term bulk supply contract, the team responds within one to two business days.

Samples

Available for pre-qualified buyers

COA / DMF

Available upon formal inquiry

10 MT/Month

Piroxicam API capacity

21 Countries

USA, UK, EU, Africa, SEA

Interested in This Product?

Contact our team to discuss pricing, availability, and custom requirements.

Quality Certifications

ISO 9001:2015

Quality Management System

FDA Compliant

Regulatory Compliance

Medical Branding

Why Buyers Choose Kodel Life

10 MT/month manufacturing capacity

IP, BP, USP & EP grades available

ISO 9001:2015 certified QMS

Supplied for capsule, topical gel, suppository & tablet formulation

Batch-specific COA with every shipment

Export to 21 countries across 5 continents

DMF reference letter support for regulated markets

Sample requests answered within 1-2 business days

Get All The Answer Of Your Question

Frequently Asked Questions

Kodel Life supplies Piroxicam API to IP, BP, USP, and EP pharmacopoeial grades. Buyers specify the required standard at enquiry stage, and the batch COA confirms compliance with the applicable monograph, covering identity, assay, related substances, residual solvents, and particle size distribution.

Production capacity for Piroxicam API is 10 MT per month. This accommodates development-scale sample requests as well as long-term commercial bulk supply contracts. Contact the team to confirm availability and lead times for your specific volume requirement.

Yes. Kodel Life supplies micronised Piroxicam API suitable for 0.5% topical gel formulation. The API meets fine particle size distribution requirements for homogeneous dispersion in PEG and carbomer-based gel bases. Photostability data and related substance profiles are available on request. Specify 'topical grade' in your enquiry to receive the matching specification sheet.

Kodel Life's Piroxicam API is suitable for four dosage forms: hard gelatin capsules, topical gel and cream, suppositories, and conventional or dispersible tablets. Dosage form-specific Technical Data Packages are available on request, covering particle size data, polymorphic form confirmation, stability data, and formulation compatibility information.

Standard documentation includes a batch COA to the specified pharmacopoeial standard, DMF or ASMF support for regulatory submissions, impurity profiles per ICH Q3A, residual solvent data per ICH Q3C, stability data per ICH Q1A, and method validation certificates per ICH Q2R1. Market-specific documentation for USFDA, EMA, or ASEAN authorities is available on request.

Yes. Kodel Life is a multi-product pharmaceutical API manufacturing company. The same ISO-certified facility produces Furosemide API (20 MT/month), Metoprolol Succinate API (20 MT/month), Metoprolol Tartrate API (62 MT/month), and Hydrochlorothiazide API (10 MT/month). Pharmaceutical buyers can consolidate cardiovascular and NSAID API procurement to a single qualified vendor.

Kodel Life exports Piroxicam API to 21 countries across Asia, Africa, Europe, and the Americas. Active markets include Thailand, Bangladesh, UAE, Saudi Arabia, Germany, USA, Canada, Brazil, Kenya, South Africa, Sri Lanka, Vietnam, and the Philippines, among others.

Yes. Kodel Life supplies the Meloxicam/Piroxicam Intermediate, the shared chemical precursor used in both Piroxicam and Meloxicam API synthesis. Manufacturers producing both NSAIDs can source the intermediate from the same qualified supplier, reducing vendor qualification burden and simplifying regulatory documentation.

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