PharmaTech
Contract development and manufacturing organization (CDMO) in Davie, Florida providing end-to-end R&D, analytical testing, regulatory support and cGMP manufacturing for prescription, OTC, dietary and nutraceutical products. Services include formulation development, pilot and commercial manufacturing of liquids, semi-solids and topicals, stability and analytical testing, method development and validation, regulatory submission support, private-label and repackaging, and nationwide logistics. The facility is FDA-registered and maintains QA/QC and cGMP processes.
Industries
Nr. of Employees
medium (51-250)
Patents
Rapamycin conjugated to peptides of up to 10 amino acid units through a carbamate linkage at position 42; coated stents; restenosis, cancer, autoimmune, transplant rejection
US-7659244-B2
View Details
Rapamycin conjugated to peptides of up to 10 amino acid units through a carbamate linkage at position 42; coated stents; restenosis, cancer, autoimmune, transplant rejection
US-7659244-B2
View DetailsProducts
Finished dosage forms: liquids, semi-solids and topicals
Commercial and pilot production of syrups, solutions and suspensions for Rx and OTC markets in various container sizes.
Dietary supplements and vitamins
Formulation and manufacturing of vitamins, nutritional supplements and related finished goods.
Private-label OTC and Rx products
Reformulation and manufacturing of OTC and Rx products for private labeling with regulatory and artwork support.
Finished dosage forms: liquids, semi-solids and topicals
Commercial and pilot production of syrups, solutions and suspensions for Rx and OTC markets in various container sizes.
Dietary supplements and vitamins
Formulation and manufacturing of vitamins, nutritional supplements and related finished goods.
Private-label OTC and Rx products
Reformulation and manufacturing of OTC and Rx products for private labeling with regulatory and artwork support.
Services
Formulation development, pilot batches, stability studies, feasibility studies, API/excipient specification and NDA/ANDA support.
Raw material and finished product testing, compendial testing, instrumental analysis and issuance of certificates of analysis.
Commercial-scale production using automated filling lines, validated purified water systems and environmental-controlled storage; minimum-batch and custom quantities available.
Private-label formulation, reformulation, regulatory label review and long-term manufacturing partnerships for OTC and Rx products.
Design and production-ready artwork for folding cartons, bottles, shrink sleeves, pouches and imprinted tubes, with regulatory review and change control.
Repackaging solutions for Rx, OTC and dietary supplements including bottle filling, blistering, pouching and master shipping pack preparation.
Formulation development, pilot batches, stability studies, feasibility studies, API/excipient specification and NDA/ANDA support.
Raw material and finished product testing, compendial testing, instrumental analysis and issuance of certificates of analysis.
Commercial-scale production using automated filling lines, validated purified water systems and environmental-controlled storage; minimum-batch and custom quantities available.
Private-label formulation, reformulation, regulatory label review and long-term manufacturing partnerships for OTC and Rx products.
Design and production-ready artwork for folding cartons, bottles, shrink sleeves, pouches and imprinted tubes, with regulatory review and change control.
Repackaging solutions for Rx, OTC and dietary supplements including bottle filling, blistering, pouching and master shipping pack preparation.
Expertise Areas
- Contract development and manufacturing (CDMO) for liquids, semi-solids and topicals
- Formulation development and pilot-to-commercial scale-up
- Analytical method development and validation
- Stability testing and ICH-compliant stability programs
Key Technologies
- High-performance liquid chromatography (HPLC) for assay and impurities
- Gas chromatography with headspace analysis
- Thin-layer chromatography (TLC) for impurity analysis
- UV-Vis spectrophotometry and diode-array detection
News & Updates
Announcement of completion of a successful inspection by the U.S. Food and Drug Administration at the company's contract development and manufacturing facility.
Announcement of significant expansion of research, development and manufacturing space at the South Florida facility.
Completed expansion of liquid dose manufacturing capacity, adding additional production lines and capacity.
Article discussing reasons to domestically outsource OTC generic manufacturing due to quality assurance concerns with overseas manufacturers.
Announcement of completion of a successful inspection by the U.S. Food and Drug Administration at the company's contract development and manufacturing facility.
Announcement of significant expansion of research, development and manufacturing space at the South Florida facility.
Completed expansion of liquid dose manufacturing capacity, adding additional production lines and capacity.
Article discussing reasons to domestically outsource OTC generic manufacturing due to quality assurance concerns with overseas manufacturers.