Pharmaffiliates Analytics & Synthetics

Pharmaffiliates Analytics & Synthetics

About

Company description

Pharmaffiliates Analytics & Synthetics (P) Ltd, is an integrated CRO (Contract Research Organization) established in year 2001. Presently we are US-FDA Audited & Accepted Facility and bagged with ISO 17034, ISO 17025 & ISO 9001 Certification. We are specialized in research via synthesis of complex and difficult to make compounds (Impurities & Metabolites), innovative organic molecules to support and accelerate the drug discovery research of pharma and biotech companies. We adapt unique synthetic approaches and execute in robust ways for making complex and unknown impurities with their characterization data. Thus we make the drug discovery process more efficient, cost-effective while maintaining the highest standards of quality. With the collective efforts of our team of 130 scientists so, far, we have performed more than 300 method validations & many of these validation reports submitted to EU & US & sought approvals. Work is carried in line with the ICH and the cGMP guidance.
Our experience, combined with state-of- the-art laboratories and manufacturing facilities lets us become an ideal partner for the pharmaceutical and drug discovery industry , we undertake projects for Process Research, Scale up , Custom Synthesis, CRAMS, Impurity synthesis, Isotope labeled compounds (Deuterium Compounds), Chiral Compounds, Phytochemicals, Glucuronides, Reference Standards, Polymorphism studies, Analytical Method Development & Validation, Stability studies & Evaluation are of our core group activities. 

So far we have successfully established a library of more than 30000 compounds with their complete characterization data. 

Our Products & Services : 

1. CUSTOM SYNTHESIS     
A. Impurities & Metabolites     
B. Stable Isotopes - Deuterium & Labelled Compounds     
C. Typical compounds - Dimers, trimers, etc.     
D. Pesticides, Phytochemicals, Petrochemicals 

2. ANALYTICAL SERVICES     
A. Identification of Unknown Impurities     
B. Impurity Profiling     
C. Method Development & Method Validation     
D. Stability Studies     
E. Transfering Technologies of APIs     
F. Forced Degradation Studies 

3. REGULATORY SERVICES     
A. DMF Filing     
B. Dossier Preparation     
C. Process Development     
D. New Molecule Development     
E. Third Party Audits  

4. CRAMS      
FTE, Fixed Bid, Milestone based options 

Each and every Standard supplied with detailed COA including the complete structure elucidation and interpretation supported data i.e  IR, NMR, MASS & HPLC Chromatogram. Also any additional data like 13C-NMR, C-HNS, Q-NMR & TGA can be provided on special request. Majority of our Impurities are above 95% purity. Impurities and standards which are not available in our catalogue can be Custom Synthesized as per your requirement. 

Quick facts

Sales markets Western Europe; Eastern Europe; Middle East; Asia; Australia; North America; Africa; Central/South America
Affiliated categories: Analytical Chemistry |Analytical Development |Analytical Methods More

Upcoming events

16 sep 2019

CPHI Middle East & Africa 2019

16 -18 September 2019 ADNEC, Abu Dhabi, UAE Visit us at stand D81 Book a meeting See our Exhibitor Profile   See full Exhibitor List
5 nov 2019

CPhI Worldwide 2019

5-7 November 2019 Frankfurt, Germany Visit us at stand 80L43 Book a meeting See our Exhibitor Profile   See full Exhibitor List
26 nov 2019

CPhI & PMEC India 2019

26 - 28 November 2019 India Expo Centre, Greater Noida, Delhi NCR Visit us at stand 4.G15 Book a meeting See our Exhibitor Profile   See full Exhibitor List

Recently at

12 mar 2019

CPhI South East Asia 2019

12-14 March 2019 Bangkok, Thailand We were at stand Q19 See our Exhibitor Profile   See full Exhibitor List
12 dec 2018

CPhI & PMEC India 2018

12-14 December 2018 India Expo Centre, Greater Noida, Delhi NCR We were at stand 2.B14 See our Exhibitor Profile   See full Exhibitor List
9 oct 2018

CPhI Worldwide 2018

9 - 11 October 2018 Madrid, Spain We were at stand 9K2 See our Exhibitor Profile   See full Exhibitor List