Stability Testing, ICH Zone IVb (30°C / 75% RH), Barbados

Stability Testing, ICH Zone IVb (30°C / 75% RH), Barbados
Product Description

Products registered across the Caribbean, Brazil, India and the ASEAN markets require stability data generated at ICH Zone IVb conditions, 30°C ±2°C and 75% relative humidity ±5%. Data from a European laboratory at 25°C and 60% RH will not satisfy those regulators.

Barbados sits in Zone IVb. BPI's national sector strategy scopes a dedicated stability testing centre: validated chambers with continuous temperature and humidity monitoring, 21 CFR Part 11 compliant electronic data capture, and qualified storage capacity, offered as a Caribbean-wide testing service.

We are at CPHI Milan to find the partners who would build and run it: laboratory operators, chamber and equipment suppliers, and anchor customers who would use the capacity.

Read more Show less

Barbados Pharmaceutical Inc.

  • Country/Region:
    Barbados
  • Founded:
    2023
  • On CPHI since:
    2026
  • Employees:
    1 - 24
Company types
Association/Government
Biopharmaceutical company
Distributor/Import Export
Drug delivery device Supplier/Manufacturer
Finance
Generics/Biosimilars Manufacturer
Innovation cluster
Pharmaceutical company
Wholesale/Retail
Primary activities
API Producer
Biopharmaceutical
Contract Manufacturer
End-product distributor (Wholesale)
Finished Formulation products Distributor/Buyer
Generic APIs producer
Intermediates Manufacturer
Laboratory Services
Medical Devices
Packaging & drug delivery
Pharmaceutical Company (generic finished products)
Supply Chain
View company profile
Categories
more categories Show less
Specifications
  • Details
    • Conditions: 30°C ±2°C, 75% relative humidity ±5%. ICH climatic Zone IVb
    • Study types under consideration: long term, accelerated, intermediate
    • Infrastructure: validated chambers with continuous temperature and humidity monitoring, 21 CFR Part 11 compliant electronic data capture, qualified storage capacity
    • Application areas: registration dossiers for the Caribbean, Brazil, India and ASEAN markets. Shelf-life justification. Post-approval change support
    • Location: Barbados, which sits in Zone IVb
    • Scope: Partners sought.
  • Selling Points
    Place of Origin; Product Features;
    • ICH Zone IVb conditions, 30°C ±2°C and 75% RH ±5%
    • Barbados sits in the climatic zone the data has to represent
    • Serves registration into Caribbean, Brazilian, Indian and ASEAN markets
    • Scoped in the national sector strategy, partners and anchor customers sought
  • Model
    ICH Zone IVb
  • Supplied from
    Barbados
More specifications Fewer specifications
Sales Markets
Show more Show less

Barbados Pharmaceutical Inc.

  • Country/Region:
    Barbados
  • Founded:
    2023
  • On CPHI since:
    2026
  • Employees:
    1 - 24
Company types
Association/Government
Biopharmaceutical company
Distributor/Import Export
Drug delivery device Supplier/Manufacturer
Finance
Generics/Biosimilars Manufacturer
Innovation cluster
Pharmaceutical company
Wholesale/Retail
Primary activities
API Producer
Biopharmaceutical
Contract Manufacturer
End-product distributor (Wholesale)
Finished Formulation products Distributor/Buyer
Generic APIs producer
Intermediates Manufacturer
Laboratory Services
Medical Devices
Packaging & drug delivery
Pharmaceutical Company (generic finished products)
Supply Chain
View company profile

More Products from Barbados Pharmaceutical Inc. (8)

  • Biologics and Biosimilars Partnership, Barbados

    Product Biologics and Biosimilars Partnership, Barbados

    Barbados's national sector strategy places biologics feasibility in Phase 3, 2030 to 2035, alongside API synthesis feasibility and regional R&D anchored at the Barbados Living Laboratory. 

    A 2030 build needs its partners identified in 2026. BPI is at CPHI Milan to open those conv...
  • CARICOM Market Access and Regulatory Pathway

    Product CARICOM Market Access and Regulatory Pathway

    CARICOM is a set of markets with no single registration route. Manufacturers who could serve the region often do not, because the pathway is unclear and no one market justifies the effort on its own.

    Barbados is building national regulatory capability, and regional review is available th...
  • Pharmaceutical Manufacturing Investment and Partnership, Barbados

    Product Pharmaceutical Manufacturing Investment and Partnership, Barbados

    BPI was established by the Government of Barbados to build pharmaceutical manufacturing capability and position the country as a production and distribution point for CARICOM and the Global South.

    BPI holds the national pharmaceutical sector strategy. For a manufacturer or investor weigh...
  • Pharmacovigilance and Post-Market Surveillance, Caribbean

    Product Pharmacovigilance and Post-Market Surveillance, Caribbean

    Manufacturers selling into Caribbean markets carry pharmacovigilance and post-market surveillance obligations, with very little capacity in the region to meet them.

    Barbados holds genomic sequencing and molecular diagnostics capacity at the Barbados Living Laboratory, launched at the Best-do...
  • Regional Bioequivalence Centre for CARICOM, Barbados

    Product Regional Bioequivalence Centre for CARICOM, Barbados

    Generic manufacturers registering into CARICOM run their bioequivalence studies outside the region or through a small number of bridging facilities elsewhere in the Caribbean. Either route adds cost and schedule to every submission, with in vivo studies running to six figures per product.

    ...
  • Regional Distribution and Supply into CARICOM

    Product Regional Distribution and Supply into CARICOM

    CARICOM is a set of small markets that most manufacturers treat as not worth serving one country at a time. Aggregated, the demand is real, and the Eastern Caribbean is reached from Barbados.

    PAHO operates its regional public health hub for the Eastern Caribbean from Barbados.
    ...
  • Sterile Manufacturing Partnership, Barbados

    Product Sterile Manufacturing Partnership, Barbados

    BPI is forming a joint venture to build sterile manufacturing in Barbados, starting with intravenous solutions. This would be the first sterile capability in the country. 

    BPI holds the national pharmaceutical sector strategy and takes equity positions in manufacturing joint ventures...
  • Technology Transfer and Contract Manufacturing Partnership, Barbados

    Product Technology Transfer and Contract Manufacturing Partnership, Barbados

    BPI is building pharmaceutical formulation capacity in Barbados and is looking for technology transfer partners: established manufacturers with proven products and processes seeking a production base for CARICOM and the Global South.

    BPI's transfer framework covers 5 components: f...