biospectra 产品代理

产品分类 > 标准品 > biospectra 产品代理

biospectra 产品代理

BioSpectra是一家总部位于美国的GMP、医药级成分制造商,包括活性物质、赋形剂、GMP工艺化学品和批量GMP缓冲液和溶液。我们的重点是小分子合成和真正的相变多步骤纯化,用于传统和生物制药应用。我们的服务包括合同GMP产品开发,以及持续的商业制造和监管支持,包括DMF提交。我们所有的制造过程都经过充分验证。我们的US-GMP监管包符合IPEC和ICHQ7指南。我们的现场分析测试能力包括多药典和定制规范,以及所有原材料和来源的完全可追溯性和透明度。我们致力于质量、合规性和真实性,US-GMP制造、测试和监管支持无与伦比
价格: 0.00

Active Pharmaceutical Ingredients (APIs)

Biological Buffers and Denaturants (Bulk GMP)

Carbohydrates (Bulk GMP)

Excipients (Bulk GMP)

Parenteral Ingredients, Low Bioburden, Low Endotoxin

Reagent/Process Chemicals (GMP/non-GMP)

Lab/Diagnostic Chemicals (non-GMP)

Solutions (Bulk GMP)

TRIS - All Products

TRIS HCl - All Products

Urea - All Products



BioSpectra is a US Based manufacturer of GMP, pharmaceutical grade ingredients, including Actives, Excipients, GMP Process Chemicals & Bulk GMP Buffers and Solutions. Our focus is small molecule synthesis and true, phase change multistep purification for both traditional and bio-pharmaceutical applications.  Our services include Contract GMP product development coupled with ongoing commercial manufacturing and regulatory support up to and including DMF submissions.  All our manufacturing processes are fully validated.  Our US-GMP regulatory package complies with IPEC & ICHQ7 guidelines. Our onsite analytical testing capabilities include multi-compendial and custom specifications with full traceability and transparency of all raw materials and sources. Our commitment is to quality, compliance and true, US-GMP manufacturing, testing and regulatory support is unparalleled.  We own and operate out of 175,000 square feet of FDA registered & inspected GMP manufacturing space, operating under the most rigorous quality system while holding to the most stringent regulatory demands. Our goal is to be a valued partner in the secure supply chain and the solution to any key ingredient issue our customers may have.


下一个: Biospec 产品代理