BIOSPECTRA
Bulk GMP Fine Chemical Manufacturer
Bulk GMP Fine Chemicals exclusively manufactured in North America
BioSpectra Inc. (BSI)는 세계 유수의 바이오 제약사들과 함께하는 고품질 의약품 원료 및 대량 cGMP 정밀화학물질의 미국 현지 제조 전문 기업입니다. BSI는 혁신적인 정제 및 합성 기술을 바탕으로 의약품 제조 공정의 전 단계(Upstream, Midstream, Downstream)를 아우르는 cGMP 최종 제품을 제공합니다.
BSI는 cGMP 제조 분야의 선두주자로서, GMP 생물학적 완충제(Biological Buffers), GMP 완충액(Buffer Solutions), GMP 공정용 정밀화학물질, 그리고 **IPEC 및 ICH Q7 규정을 준수하는 신규 화합물(NCEs)**까지 다양한 제품 포트폴리오를 보유하고 있습니다.
특히 **소분자 합성(Small Molecule Synthesis)**과 **정밀 다단계 정제 공정(Phase-change Multi-step Purification)**에 강점을 가지고 있어, 의약품 개발 및 생산의 다양한 단계에서 발생하는 주요 원료 이슈에 효과적인 솔루션을 제공합니다.
Galactose / Trehalose Dihydrate / Dextran Polymers
Functional CarbohydratesGalactose / Trehalose Dihydrate / Dextran Polymers
Exclusively Manufactured In North America
cGMP Fine ChemicalsExclusively Manufactured In North America
Prurified Buffers for Up and Downstream Applications
GMP Bulk Bio-BuffersPrurified Buffers for Up and Downstream Applications
Functional Molecules and New Chemail Entities
Excipients &NCEsFunctional Molecules and New Chemail Entities
Bulk & Custom GMP Chemicals for Pharma Products
Custom ManufacturingBulk & Custom GMP Chemicals for Pharma Products
Product Categories
Purification
GMP Solutions
Pharmaceutical Ingredient Manufacturing Bulk Manufacturing Facility & Head Corporate Offices: Administration, Regulatory Affairs, Quality Assurance & Control Address: 100 Majestic Way, Bangor, PA 18013 Staff: 125+ Employees I Site: 150,000 sq. ft. on 37+ Acres
MajesticPharmaceutical Ingredient Manufacturing Bulk Manufacturing Facility & Head Corporate Offices: Administration, Regulatory Affairs, Quality Assurance & Control Address: 100 Majestic Way, Bangor, PA 18013 Staff: 125+ Employees I Site: 150,000 sq. ft. on 37+ Acres
Biological Buffer Manufacturing Bulk Manufacturing Facility, Quality Assurance & Control Address: 1474 Rockdale Lane, Stroudsburg, PA 18360 Staff: 50+ Employees I Site: 25,000+sq. ft. on 3+ Acres
RockdaleBiological Buffer Manufacturing Bulk Manufacturing Facility, Quality Assurance & Control Address: 1474 Rockdale Lane, Stroudsburg, PA 18360 Staff: 50+ Employees I Site: 25,000+sq. ft. on 3+ Acres
Supply Chain Center Shipping and Receiving & Security HQ Address: 51 N 3rd Street, Stroudsburg, PA 18360 Staff: 20+ Employees I Site: 60,000sq. ft. on 2+ Acres
McConnellSupply Chain Center Shipping and Receiving & Security HQ Address: 51 N 3rd Street, Stroudsburg, PA 18360 Staff: 20+ Employees I Site: 60,000sq. ft. on 2+ Acres
Biospectra Canada d.b.a - Dextran Products Address: 421 Comstock Rd, Scarborough, ON MIL 2H5, Canada
ComstockBiospectra Canada d.b.a - Dextran Products Address: 421 Comstock Rd, Scarborough, ON MIL 2H5, Canada
Corporate Services Center Commercial, IT. HR, Finance & Training Center Address: 1349 Jacobsburg Road, Wind Gap. PA 18091 Staff: 30+ Employees I Site: 25,000+sq. ft. on 2+ Acres
JacobsburgCorporate Services Center Commercial, IT. HR, Finance & Training Center Address: 1349 Jacobsburg Road, Wind Gap. PA 18091 Staff: 30+ Employees I Site: 25,000+sq. ft. on 2+ Acres
BioBuffer Solutions Wet Chemistry Labs / Raw Material Warehousing Address: 51N 3rd Street, Stroudsburg, PA 18360 Completed Date - 2025
FulmerBioBuffer Solutions Wet Chemistry Labs / Raw Material Warehousing Address: 51N 3rd Street, Stroudsburg, PA 18360 Completed Date - 2025
Bulk GMP Fine Chemicals exclusively manufactured in North America
American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.
