Daicel Pharma Services provides innovative analytical solutions to support timely and safe drug development with improved cost efficiency. We support the domestic and global pharmaceutical industry from the development stage to commercialized products.

We have a dedicated and experienced team of analytical scientists and a quality assurance team capable of providing documentation support – CMC, IND-CTA, EMA, DMF, and ANDA – in line with global regulatory requirements for both drug substance and drug product (US FDA, EU and Brazilian) filings.

• First ISO: 9001-2008 accreditation: SEP 2011
• First submission of DMF: SEP 2013
• First ISO: 9001-2015 accreditation: OCT 2017
• Drug control administration inspection (Indian FDA audit): September 2019
• ISO/IEC:17025-2017 certification: January 2020
• Successful US-FDA Inspections in 2016, 2019 and 2023
• Projects Supporting (ANDA/NDA/DMF)

A wholly-owned and operated subsidiary of Daicel Corporation, Japan, our facility offers a wide range of Analytical Research and Development services.