Aceclofenac API

Aceclofenac API Manufacturer in India

Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) active pharmaceutical ingredient. Radhey Bio-Tech Pvt. Ltd. manufactures and supplies Aceclofenac API from its dedicated API manufacturing facility in Udaipur, Rajasthan, for pharmaceutical manufacturers in domestic and international markets.

Manufacturing & Quality

Aceclofenac API is produced at a CDSCO-licensed API manufacturing facility aligned with Indian GMP requirements under Schedule M, with ICH Q7-aligned quality systems. The facility has 49 reactors (31 stainless steel and 18 glass-lined) and an annual manufacturing capacity of 200 MT.

Quality is supported by QA, QC and IPQC functions and in-house analytical testing including HPLC, GC, FTIR and UV-Visible spectrophotometry. Learn more about our facility.

Quality & Regulatory Documentation

Aceclofenac API is supported by comprehensive technical and quality documentation, including:

• Certificate of Analysis (COA)
• Product Specifications
• Technical Data Sheet (TDS)
• Material Safety Data Sheet (MSDS)
• Method of Analysis (MoA)
• Stability Data
• DMF, where applicable
• Batch Traceability
• Regulatory Documentation