Profile
Calyx has a 28-year history of building up successful partnerships.Calyx is poised to actively participate in this growing opportunity ofoutsourcing and contract manufacturing. It is the one stop solution providerfor Custom Synthesis, FTE Research,Contract Manufacturing, Analytical services Intermediatesand APIs.
The multipurposemanufacturing plants have capabilities to produce in compliance with cGMP, USFDA, WHO, EDQM, ISO, IHS and COS norms, while, ourglobal footprint includes marketing and sales offices in US, Japan and sourcing office in China. Thisenhanced communication and working 24x7 fosters business relations.
Calyx, over the years, has systematically harnessed resources anddeveloped a capability that spans the entire spectrum of vital services. Itincludes focus on integrated chemistry solutions ranging from discoverychemistry, route scouting, process research, scale up and analytical support.Capability to handle critical and innovative chemistry ensures deliveringdiverse molecules from grams to tons in timely and cost effective manner.Commitment to IPR and CDAs supported with system security and firewall ensuressmooth project management.
Latest creation of newR&D facility is geared up to house 300 scientists, with Process Labs, cGMP Kilo Labs, Analytical Labs, along with cGMP Pilot Plant facility to ensure enhanced productivityfor CRAMS (Contract Research and Manufacturing Services).
In the past few years, the Company has entered intoagreements with companies across the world and has become an integralpart of their supply chain.
Calyxoffers a range of APIs, chemical intermediates and building blocks toPharmaceuticals, Biotech, Chemical and Drug discovery companies. Thisincludes Pyrazines, Pyridines, Tetrazoles,benzimidazoles, Thiazoles, Methylenedioxy phenyl derivatives, Protectedamino acids, Dipeptides, Zopiclone,Pyrazinamide, Erythromycin salts and many more.
Passion for excellence andcommitment in quality, safety, environment and technical capabilities enables Calyx to deliver in a highlyprofessional manner and with a sense of urgency while upholding the highestbusiness ethics.
Services ..FTE and FFS
ü Custom Syntheses
ü Contract Manufacturing
ü Contract research
ü Analytical services
ü Intermediates and APIs
ü Building blocks /Libraries
ü Route scouting
ü Process improvement
ü Scale up
ü GMP Validation batches
ü Process and cleaning validation studies
ü Impurity profiling
Project Spectrum
ü Intermediates for NCEs
ü Intermediates for APIs
ü Building blocks
ü Generic bulk drugs
ü Semi-Synthetic modification of natural products
AnalyticalServices
ü Stability testing
ü Analytical method development and Validation
ü Force degradation
ü Residual solvent validation
ü Spectral data–NMR(400MHz), GC-MS, LC-MS & FTIR
ü Bio-Analytics
Chemistry
ü Pyrazines
ü Azide chemistry (Tetrazoles)
ü Hydrazide chemistry
ü Benzimidazoles
ü Pyrrolopyrazines
ü Cryogenic reactions
ü Hydrogenation
ü Halogenation
ü Borohydride reduction
ü Hofmann rearrangement
ü Sonocrystallization/sonochemistry
The Calyx IndiaAdvantage
ü Services …one stop shop(grams to tons)
ü Quality ….with cost competitiveness
ü Reliability …..…track records
ü Strong R&D … delivering diverse chemistries from single to multi-step synthesis
ü GMP Kilo Labs and GMP Pilot plant
ü Compliance to USFDA, WHO-EDQM , cGMP andInternational customers
ü Technology … integrating with innovative chemistry
ü Project management …speed with transparent communication
ü In the supply chain of innovator companies
ü 28-Year history of successful partnerships
ü Business ethics …respecting CDA and IPR
ProjectManagement
ü Well defined deliverables
ü A dedicated team of scientists/ project managers for each project
ü Working 24x7 to honor commitments with agility
ü Involvement of customer during development
ü Mutually agreed documentation
ü Well equipped Analytical laboratories including NMR (400MHz), GC-MS,HPLCs, HPTLC, FTIR, GCs, Elemental analyzer etc.
ü More than 200 scientists…postgraduates, doctorates,post-doctorates and chemical engineers
ü Dedicated scientists for Informatics …utilizing latest chemistrysoftware
ü Technology support team
ü Regulatory support team
ü Efficient logistics
ü Periodic review …Tele/Video Conferencing and Net meetings
ü Knowledge sharing
ü Administrative and Legal support for Reporting, Communications andConfidentiality
Disclaimer
*The technical & physical manufacturingcapabilities exist with us for the following APIs and their intermediates.However these products will be offered only to the markets where any product orprocess patents are not infringing. During the validity of the patent, theresearch quantities for developing products for submissions will only beoffered to the countries where such exemption exists (Hatch Waxman Act, Bolar Act). While Calyx offers to work with the clients onPatent Status Verification, the final responsibility vests with the buyer.Recipients are requested to make their evaluation and determination as to thepatent status prior to their use of information or materials in their respectivejurisdiction. Products under patent are offered only for exempted Research,clinical and developmental purposes.
