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BioSpectra




Country: USA

BioSpectra
100 Majestic Way
Bangor, PA 18013


Phone: 610-599-3427
FAX: 610-599-3410
E-Mail:E-Mail this Supplier


http://www.biospectra.us

GMP Product Categories:
  • Active Substances
  • GMP Custom Products
  • Excipients and Key Ingredients
  • GMP Process Chemicals and Solutions
  • Bulk, GMP Biological Buffers & Denaturants

Custom GMP Products:

  • Purification of Key Ingredients
  • Full GMP Product Development
  • Small Molecule Custom Synthesis
  • API Development & Manufacturing
  • GMP Compounded Solvents & Solutions

Exclusively Manufactured in the USA - APIs / Excipients / Critical GMP Process Chemicals

FDA Registered and Inspected, ICH Q7, IPEC & US GMP Compliant, BioSpectra exclusively manufactures all its products at its state-of-the-art GMP facilities in Bangor and Stroudsburg PA, USA. Products include APIs, Excipients, GMP Bulk Biological Buffers, GMP Process Chemicals, and unique GMP Compounded Solvents and Solutions. In addition, BioSpectra offers a range of contract, custom GMP manufacturing services and Lab support.

BioSpectra operates out of 175,000 square feet of GMP manufacturing and storage facilities. We adhere to the most rigorous quality system while upholding the highest regulatory standards. Our goal is to become a valued partner in your secure supply chain and the solution to any key ingredient issue you may have.

COMPREHENSIVE QUALITY & REGULATORY SYSTEM

  • FDA Registered & Inspected
  • Full Transparency in Documentation
  • Stringent Quality Program & Controls
  • Document Support - DFM Submissions
  • Rigorous compliance to Global Standards
  • FDA & ICH Q7 Guidance for Drug Substances
  • Global GMP Requirements - US, IPEC, ICH Q7
  • State-of-the-art Instrumentation & Laboratories
  • Culture of Embracing Evolving Regulatory Demands
  • Complete Testing of all Raw Material and Finished Products

True US GMP Manufacturing of Premium Pharmaceutical Ingredients

  • True GMP Product Claim - Always Synthesized and/or Purified not simply tested and repackaged
  • Reliable, Consistent, Uniform, Quality-Based Manufacturing of Premium Pharmaceutical Ingredients
  • Authentic, Secure Supply Chain - 100% Traceable Raw Materials from Qualified Sources
  • Fully Validated GMP Manufacturing Systems & Qualified Equipment
  • Exclusively Manufactured in the USA

Product List: 37

PON:Page:


 


keywords

24-DIHYDROXYPYRIMIDINE; 24(1H3H)-PYRIMIDINEDIONE;
24-PYRIMIDINEDIOL
BIOSPECTRA
BROMIDE SALT OF POTASSIUM
CARBAMIDE
CARBONYLDIAMIDE
GUANIDINE
GUANIDINE CHLORIDE
GUANIDINE HCL
GUANIDINE HYDROCHLORIDE SOLUTION
GUANIDINE ISOTHIOCYANATE
GUANIDINE MONOHYDROCHLORIDE
GUANIDINIUM CHLORIDE
GUANIDINIUM HYDROCHLORIDE
KALII BROMIUM
MONOHYDROCHLORIDE
THAM
TRIS BASE
TRIS BUFFER
TRIS HCL
TRISAMINE
TRIZMA
TROMETAMOL
TROMETAMOL HYDROCHLORIDE
TROMETHAMINE
TROMETHAMINE HCL
TROMETHAMINE HYDROCHLORIDE


Product List

GUANIDINE HYDROCHLORIDE
CAS:50-01-1
Formula: CH5N3HCl
GMP Pharmaceutical Ingredient
Excipient
GH4220 / GH3220
GUANIDINE THIOCYANATE
CAS:593-84-0
Formula: C2H6N4S
GMP Pharmaceutical Ingredient
Excipient
GT4220 / GT3220
HEPES, FREE ACID
CAS:7365-45-9
Formula: C8H18N2O4S
GMP Pharmaceutical Ingredient
Excipient
HE4220 / HE3220
MES, MONOHYDRATE
CAS:145224-94-8
Formula: C6H13NO4S.H2O
GMP Pharmaceutical Ingredient
Excipient
ME4220 / ME3220
MOPS, FREE ACID
CAS:1132-61-2
Formula: C7H15NO4S
GMP Pharmaceutical Ingredient
Excipient
MP4220 / MP3220
POTASSIUM BROMIDE
CAS:7758-02-3
Formula: KBr
API
PB2220
TRIS / TROMETHAMINE
CAS:77-86-1
Formula: C4H11NO3
GMP Pharmaceutical Ingredient
API FUISA
TR4220 / TR3220 / TR2220 / TR1220
TRIS HYDROCHLORIDE
CAS:1185-53-1
Formula: C4H11NO3HCl
GMP Pharmaceutical Ingredient
Excipient API
TH4220 / TH3220 / TH2220
URACIL
CAS:66-22-8
Formula: C4H4N2O2
GMP Pharmaceutical Ingredient
UC4220
UREA
CAS:57-13-6
Formula: CH4N2O
GMP Pharmaceutical Ingredient
Excipient API
UR4220 / UR3220 / UR2220