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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, and custom GMP manufacturing services. 

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: 38

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Product List

6N HCL IN IPA
CAS:67-63-0
Formula: HCl / C3H8O
GMP Pharmaceutical Ingredient
IH4101
GALACTOSE
CAS:59-23-4
Formula: C6H12O
Excipient
GA3250
GUANIDINE HYDROCHLORIDE
CAS:50-01-1
Formula: CH5N3·HCl
GMP Pharmaceutical Ingredient
GH4220
GUANIDINE HYDROCHLORIDE 6M
CAS:50-01-1
Formula: CH5N3·HCl
GMP Pharmaceutical Ingredient
GH4120
GUANIDINE THIOCYANATE
CAS:593-84-0
Formula: C2H6N4S
GMP Pharmaceutical Ingredient
GT4220
HEPES, FREE ACID
CAS:7365-45-9
Formula: C8H18N2O4S
GMP Pharmaceutical Ingredient
HE4220
MES, MONOHYDRATE
CAS:145224-94-8
Formula: C6H13NO4S·H2O
GMP Pharmaceutical Ingredient
ME4220
MOPS, FREE ACID
CAS:1132-61-2
Formula: C7H15NO4S
GMP Pharmaceutical Ingredient
MP4220
SODIUM DECANOATE
CAS:1002-62-6
Formula: C10H19NaO2
Excipient
ND3220
SUCROSE
CAS:57-50-1
Formula: C12H22O11
Excipient
SB3250
TREHALOSE, DIHYDRATE
CAS:6138-23-4
Formula: C12H22O12·2H20
Excipient
TE3250
TRIS
CAS:77-86-1
Formula: C4H11NO3
GMP Pharmaceutical Ingredient
TR4220
TRIS HYDROCHLORIDE
CAS:1185-53-1
Formula: C4H11NO3·HCl
GMP Pharmaceutical Ingredient
TH4220
URACIL
CAS:66-22-8
Formula: C4H4N2O2
GMP Pharmaceutical Ingredient
UC4220


keywords

BIOSPECTRA
BROMIDE SALT OF POTASSIUM
CARBAMIDE
DIHYDRATE
GUANIDINE
GUANIDINE CHLORIDE
GUANIDINE HCL
GUANIDINE HCL 6M
GUANIDINE HCL SOLUTION
GUANIDINE HYDROCHLORIDE SOLUTION
GUANIDINIUM CHLORIDE
GUANIDINIUM HYDROCHLORIDE
HEPES
MES
MOPS
SODIUM HYDROXIDE SOLUTION
TREHALOSE
TRIS BASE
TRIS BUFFER
TRIS HCL
TRIZMA
TROMETHAMINE
TROMETHAMINE HCL
TROMETHAMINE HYDROCHLORIDE