WHO-GMP certified API production with complete DMF support.
Availability: In Stock | CAS: 22071-15-4 | Grade: IP/BP/USP
Surya Life Sciences Ltd. is a Ketoprofen API manufacturer and supplier offering WHO-GMP certified bulk production with complete DMF support. Our ketoprofen API is supplied to regulated and semi-regulated markets with consistent quality, controlled impurity profiles, and reliable batch performance. As a pharmaceutical API manufacturer in India, Surya Life Sciences also specializes in NSAID API manufacturing and global bulk supply.
Surya Life Sciences Ltd. is a leading ketoprofen API manufacturer and supplier offering WHO-GMP certified bulk production with complete DMF support to regulated and semi-regulated markets worldwide.
Our four WHO-GMP–approved manufacturing facilities, certified to ISO 9001:2015, operate in compliance with applicable quality, safety, and environmental regulations. All production batches comply with IP, BP, and USP pharmacopeial standards.
Ketoprofen API Key Specifications
| Attribute | Specification |
|---|
| Chemical Name | (RS)-2-(3-Benzoylphenyl)propanoic acid |
| CAS | 22071-15-4 |
| Category | Non-Steroidal Anti-Inflammatory Drug (NSAID) |
| Therapeutic Use | Analgesic and anti-inflammatory applications |
| Molecular Formula | C16H14O3 |
| Molecular Weight | 254.28 g/mol |
| Appearance | White or almost white crystalline powder |
| Solubility | Practically insoluble in water, freely soluble in acetone, ethanol 96% and in methylene chloride |
| Melting Point | 93°C to 96°C |
| Purity | Contains not less than 980 and not more than 1020 of C16H14O3 calculated on the anhydrous basis |
| Shelf Life | |
| Available Grades | IP/BP/USP |
Why Choose Us as Your Ketoprofen API Manufacturer?
At Surya Life Sciences, Ketoprofen API manufacturing is supported by controlled processes, validated analytical methods, and regulatory-aligned quality systems. Our focus is on consistency, documentation integrity, and dependable supply. Our expertise as an NSAID API manufacturer ensures consistent quality across multiple therapeutic categories.
Here’s why global leaders keep coming back to us:
Regulatory-Ready Documentation & DMF Support
We provide documentation designed to support development, registration, and commercial supply, including:
- Drug Master File (DMF) support
- IP/BP/USP compliance data
- Method validation reports, stability data, and batch-specific Certificates of Analysis
Reliable Stock Availability & Supply Continuity
Our production planning and inventory controls support an uninterrupted supply:
- Stock-based and made-to-order supply options
- Typical dispatch timelines of 7 days, subject to batch availability
- Long-term supply planning for commercial programs
Easy Ordering & Reasonable Pricing
Ordering options are aligned with different stages of pharmaceutical development:
- R&D quantities
- Pilot and validation batches
- Commercial-scale supply at competitive pricing
Certified Quality & Compliance
Our manufacturing operations align with internationally recognised standards:
- WHO-GMP–approved facilities
- ISO 9001:2000
- ISO 14001:2004
- OHSAS 18001:1999
- Compliance with applicable pharmacopeial, environmental, and safety requirements
Bulk Ketoprofen API Manufacturer & Supply Capabilities
Surya Life Sciences supplies Ketoprofen API in bulk quantities with defined production and delivery timelines. We support bulk API supply requirements for pharmaceutical companies and contract manufacturing organizations worldwide.Current supply capacity is up to 5,000 kilograms per month.
Customization Options:
- Flexible batch sizes based on order quantity and production planning
- Customized packaging formats on request to meet regulatory or logistical requirements
Clinical Uses & Industry Applications of Ketoprofen API
Ketoprofen API is used in regulated pharmaceutical formulations for pain and inflammatory conditions, including:
Rheumatoid arthritis and osteoarthritis
Acute musculoskeletal pain and postoperative pain
Dysmenorrhea and other inflammation-associated pain conditions
Key industry applications of Ketoprofen API include:
Oral Solid Dosage Form Manufacturing
Used in the manufacture of tablets and capsules intended for systemic pain and inflammation management, where controlled assay, impurity limits, and pharmacopeial compliance are required.
Topical and Transdermal Pharmaceutical Formulations
Applied in topical gels, creams, and transdermal preparations designed for localized anti-inflammatory and analgesic action under regulated manufacturing conditions.
Parenteral and Injectable Drug Manufacturing
Supplied for use in injectable dosage forms intended for acute pain management in hospital and clinical settings, requiring stringent quality and sterility controls.
Generic Drug Development & ANDA Programs
Used in generic formulation and registration programs requiring pharmacopeial compliance and batch-to-batch reproducibility.
Contract API Manufacturing & Long-Term Supply
Supplied to CDMOs and pharmaceutical companies for contract manufacturing, scale-up, and commercial sourcing of Ketoprofen API.
Storage, Packaging & Handling Information
Storage
Store in a well-closed container, protected from light.
Packaging
Packed in HDPE drums or cargo boxes with appropriate inner liners.
Handling
Handle in accordance with GMP and MSDS guidelines using appropriate Personal Protective Equipment (PPE).
Contact a Ketoprofen API Manufacturer for Pricing & Bulk Orders
Connect with our experts for pricing, availability, technical documentation, regulatory assistance, tailored supply options, and more.
FAQs
Is Ketoprofen API pharmacopeia compliant?
Ketoprofen API is manufactured in compliance with IP, BP, and USP standards, with defined specifications for identity, purity, and quality.
Are DMFs applicable to regulated and semi-regulated markets?
Yes. Surya Life Sciences supports Drug Master Files (DMFs) and associated regulatory documentation for Ketoprofen API, subject to regional requirements.
What is the typical delivery time for bulk Ketoprofen API orders?
Ketoprofen API orders are typically dispatched within 7 days of confirmation, subject to batch availability and final quality release.
What is the minimum order quantity (MOQ) for Ketoprofen API?
The minimum order quantity (MOQ) for Ketoprofen API is 100 kg. API-specific MOQs can be reconfirmed with the commercial team.