Overview
Tapemark is a world leading contract developer and manufacturer of specializing in the innovation of transdermal, oral thin film, and unit dose semi-solid drug delivery serving the pharmaceutical and medical device markets. Tapemark is a full-service Contract Development and Manufacturing Organization (CDMO) that provides high-quality services under a strong quality system and excellent regulatory compliance record. The company was founded in 1952 and is based in St. Paul, Minnesota.
Company Services
Services/CapabilitiesCDMO
+ Biologic Manufacturing Capacities
+ Development Services
- Analytical Development & Validation
- Bioanalytical Services
- Compendial Testing
- Extractables/Leachables Studies
- Preformulation/Formulation
- Process Development & Validation
- Raw Material Testing
- Release & QA/QC Testing
- Scale Up/Tech Transfer
- Stability Testing
+ Drug Product Manufacturing
- Clinical Trial Material Manufacturing
- Continuous Manufacturing
- Controlled Substance Drug Products
- Cytotoxic / High Potency Compounds (OEL < 1µg/m3)
- Dedicated Suites
- Liquid/Semi-Solid Dosage Manufacturing (Non Sterile liquid, creams, ointments)
- Oral Thin Films
- Transdermal Patch
+ Packaging
- Creams/Ointments/Gels Packaging
- Anti-Counterfeiting
- Carton Packaging
- Clinical Trials Packaging
- High Speed Lines
- Labeling
- Serialization / Aggregation
- Stick packs/Sachets/Unit Dose
- Storage/Warehousing
Regulatory/CertificationsCDMO
+ EMEA/EMA (EU)
+ FDA (USA)
+ Health Canada
+ ISO 14001
+ ISO 9001
+ MFDS (Korea)
+ MHLW (Japan)
+ MHRA (UK)
+ TGA (Australia)
Focus Area/Product TypeCDMO
+ 505(b)(2) Regulatory Pathway
+ ANDA
+ Drug Delivery /Formulation
+ Formulation - Serialization and Shipment
+ NDA
+ Generics
+ Pharmaceutical - Small Molecule (Innovative)
Therapeutic CategoriesCDMO
+ Addiction Treatment
+ Cardiovascular
+ CNS
+ Dermatology
+ Endocrine & Metabolic
+ Infectious Diseases
+ Musculoskeletal, Rheumatology & Osteology
+ Oncology
+ Rare /Orphan Diseases
+ Safer Pain Therapies