9 oct 2018
CPhI Worldwide 2018
BioSpectra, Inc

BioSpectra, Inc

Exhibitor at CPhI Worldwide 2018 stand 5A70, API

About us

BioSpectra – Booth 5A70: Your Premier Partner for US-Manufactured Life-Science Chemicals, Regulatory Compliance & Product Development – Your “Bespoke” Life Science Partner: BioSpectra is the premier US-Manufacturer of Life Science Actives, Intermediates, Excipients, Biological Buffers and Custom Products.   FDA registered and inspected, we operate  under true, US-GMP, IPEC and ICHQ-7 requirements out of 175,000 square feet of state-of-the-art facilities only 2-hours from NYC in historic Pennsylvania.     BioSpectra stands apart as the only manufacturer of these products in the USA operating under these rigorous quality standards.  Our comprehensive Total-Quality-System and Regulatory Support Services exceeds any other competitor, anywhere in the world, for the products we provide.         Core Products:  ·         Actives: KBr, KCl, NaCl, Tromethamine, Urea,  & Custom APIs/ Oral, Transdermal & FUISA (For Use In Sterile Applications).  ·         Excipients & Intermediates: Tromethamine, Guanidine HCl & Thiocyanate, HEPES, L-Cystine HCl, MOPS, Sugars (Galactose, Sucrose, Trehalose), TRIS HCl, Uracil, Urea, Ammonium Sulfate  ·         Biological Buffers (GMP):  HEPES, MES, MOPS, TRIS, UREA and more…                 Custom Products   ·         Synthesis:  Alcohol / Solvent / Aqueous / Acid-Base Reactions / Chlorination / Bromination / 1kg to 1,000’s Kg   ·         Custom Solutions:  Aqueous, Solvent and Acid-Base /10L to Tank Truck  ·         Custom Products: Specifications, Packaging and Labeling   ·         Purification: Alcohol / Solvent / Aqueous        ·         Recrystallization: Alcohol / Solvent / Aqueous   ·         Particle Manipulation: Jet Milling / Blending   ·         Drying: Rotary / Fluid Bed / Spray Drying / Tray Drying                                                 Custom Services:   ·         Drug Master File (Type II and Type IV)   ·         GMP Product Development   ·         R&D   ·         Pilot scale up   ·         Test Method Development   ·         Accelerated Stability Testing   ·         Lab Services   ·         Aseptic Filling (2018)

Specs about this supplier

Sales markets Western Europe; Eastern Europe; Middle East; Asia; Australia; North America; Africa; Central/South America
Affiliated categories: API Contract Manufacturing |Biopharmaceuticals (general category) |Contract Manufacturing More

Products featured at CPhI Worldwide 2018

View all our products featured at CPhI Worldwide 2018 (9)
BioSpectra, Inc

Event information

CPhI Worldwide 2018

9 - 11 October 2018 Madrid, Spain Visit us at stand 5A70