Sun Pharma
No Booth
Mumbai, Maharashtra 400059 IN
Phone: +91 829 173 1763 Fax: +91 22 2821 2010 https://www.sunpharma.com/
Company Profile

CRAMS “Contract Research And Manufacturing Services” @ Sun Pharma

Sun Pharma, being a trusted partner for many leading global innovator and generic companies and having proven track record for the “chemical process development & manufacturing”, we have taken one step ahead and introduced the “Contract Research & Manufacturing Services (CRAMS) in the year 2019. Considering our unwavering commitment to quality, state-of-the-art research; manufacturing capabilities, regulatory and intellectual property (IP) expertise, we are geared up to support and accelerate the Innovators’ development & manufacturing programs for “Novel Chemical Entities (NCEs)” [Peptide APIs, HPAPI/Oncology, Steroids, Hormones, Penams and Controlled Substances].


As we enter this endeavor of supporting the innovators in the commercialization of their novel medicines, we offer the following services:


  • Synthetic Route Design & Scouting Services including flow chemistry
  • High-end Chemical Process Development (DoE, 6s, QBD, Salt & Polymorph) & lab demonstration
  • Analytical Method Development (AMD) & Analytical Method Validation (AMV)
  • Process Engineering (Data Generation) & Process Safety Studies (Process Hazard Analysis)
  • Salt Screening and polymorph studies
  • Impurity Profiling (including impurity & reference standard synthesis)
  • Kilo & Pilot Scale Manufacturing (non-GMP & GMP) TOX and Clinical Quantities
  • PAR (Proven Acceptance Range) & NOR (Normal Operating Range) Studies
  • Process Validation followed by Commercial Manufacturing
  • ICH Stability Studies & Support for Regulatory filing and approvals (CMC, DMF)
Categories
     Cancer
     Nucleosides and Oligonucleotides
     Therapeutic window
Contacts
Vijay Kaiwar, Ph.D., Vice President-Business Development-CRAMS and Strategic APIs
Phone: +91 22 4224 4252
Mobile: +91 829 173 1763
Fax: +91 22 2821 2010
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