Synthimed Labs Private Limited

Year of Establishment: 1995

Total Assets(USD): 500,000 to 99,999,999

Total Number of Staff: more than 1000

Main Competitive Advantages: International Approvals/Standards,Experienced R&D Staff,Delivery Term,Production Capacity,Large Product Line,Buyers' Specifications Accepted,Small Orders Accepted,Reputation,Quality Service

Other Competitive Advantages: Highlights of Our Regulatory Expertise: At our core, we strive for regulatory excellence, ensuring seamless global operations for our partners. With over 30+ successful regulatory audits and 350+ customer audits, we are proud to showcase our compliance journey spanning multiple countries and esteemed regulatory bodies, including the FDA (USA), PMDA (Japan), EMA (Europe), and many more. ✅FDA (USA): Approved for all 15 DMFs submitted, with successful inspections in 2007, 2011, 2015, 2017, 2018, and 2020. ✅PMDA (Japan): Key product approvals like Risedronate Na and Pioglitazone HCL (2010, 2017). ✅Europe: Approval for Clopidogrel and Clarithromycin with successful inspections in 2016. ✅Australia, Germany, and Beyond: Expanding global compliance with inspections from leading authorities, ensuring alignment with pharmaceutical standards. Other Key highlights: • Trusted partner for global pharma giants in 50+ countries • 3 state-of-the-art manufacturing sites with USFDA, ANVISA, and EDQM certifications • Robust R&D center with 160 dedicated scientists • Expertise in 16 therapeutic segments • Strong regulatory compliance with 16 US DMFs, 16 CEPs, and 13 Japan DMFs • Sustainable, Cost-Effective, and Scalable API Solutions

Patents and Copyrights: NB: * Products subject to patent protection are not offered or supplied for commercial purposes in countries where this constitutes an infringement of patent rights. * Products under patent protection are only available pursuant to Section 107-A (a) of the Indian Patents Act 1970.