crams

Contract Research and Manufacturing Services (CRAMS) by Megafine encompasses a set of services for Custom Synthesis, Process R&D, Scale up, Contract/toll Manufacturing of APIs, Advance Intermediates, Key Building blocks for in-market products and for NCEs from early phase development to commercialization stage.

 

Megafine with it’s integrated R&D, technology and engineering capability has served as a dependable manufacturer to leading Innovators and several Global Pharma majors by developing cost effective and non-infringing processes for various APIs & Advance Intermediates. Respect for IPR and Customer Confidentiality is a management philosophy.

 

OUR CORE STRENGTHS
     
  Custom Research and Manufacturing Services of Megafine combines:  
       
  Decades of chemistry experience in the pharmaceutical industry  
  A long & proven track record and strong relationship with top global pharmaceutical innovators and generic players  
  Unmatched experience and leadership in piperazine chemistry  
  Expertise in wide range of chemical reaction and technology platforms  
  Strong R&D, Engineering & Manufacturing capabilities across the scale of operation, from lab to pilot to plant execution for smooth scale up & commercial production  
  Facilities complying cGMP  
  Total quality management  
  Environment, Health and Safety is key management philosophy  
  Focused regulatory support  
  Robust solutions to our customers on time, every time  
  An efficient logistics and supply chain  
  A dedicated project management team  
     
SALIENT FEATURES
       
  Site area 300,000 sq. ft.  
  Total plant area 50,000 sq. ft.  
  SIX multipurpose manufacturing blocks with THREE cGMP API streams  
  APIs manufactured under class 100,000  
  Intermediates manufacturing area with 5 micron filter  
  Process water to meet USP standards  
  Total reaction capacity: 90,000 liters  
  SS, GL reactors ranging from 10 to 8000 liters  
  Multiple drying options  
  Fractional & FFE Distillation under high vacuum  
  Temperature range (-) 80⁰C to 275⁰C  
  Pressure upto 145 psi  
  Nitrogen blanketing system  
  PLC based automation system for hazardous operations  
       
REACTION CAPABILITIES
       
  Alkylations Halogenations  
  Amidations Hydrazine  
  Condensation Hydrogenation  
  Cyanations Nitrations  
  Cryogenic Oxidations  
  Etherification Piperazines  
  Esterifications Reductions  
  Formylation Resolution Tech.  
  Friedel Crafts Thiophene  
  Grignard Witting  
  Swern’s oxidation Gewald