TORONTO, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Polydex Pharmaceuticals Limited (OTC Pink: POLXF) (the œCompany or œPolydex) announced today that it has consummated the Plan of Arrangement (the...
Our focus for the show will be Low Bioburden, Low Endotoxin drug ingredients, API contract development and Solutions for other critical needs through custom synthesis, purification and full GMP product support.
In direct response to the announced COVID-19 pandemic, BioSpectra has developed a mitigation and business continuity plan.
BioSpectra would like to publish the slide deck from President Richard Mutchler’s presentation on “Determining the Value of Re-Shoring Drug Ingredient Manufacturing” and a Supply Chain Risk Assessment form. The material was presented in May at CPhI North America to a large hall and garnered positive responses. Topics included the efforts of validating foreign manufacturing to appropriate compliance guidelines, maintaining a supply chain for pharmaceuticals to ensure appropriate material intended use and evaluating the benefits of manufacturing within jurisdiction of the governing compliance agency.
BioSpectra has expanded its pilot and kilo-scale production area, R&D Staff and Engineering support team to better service the needs of our customers seeking the synthesis of smaller volumes of proprietary small-molecule excipients and APIs.
BioSpectra has completed the successful manufacture of three “Parenteral Grade” Carbohydrates: D-Galactose, Sucrose and Trehalose Dihydrate.
BioSpectra announces advancement in Carbohydrate production to include Low Elemental Impurities in the low PPB range. These stringent demands will be added to the Low Bioburden Low Endotoxin specifications for its three, recently launched carbohydrate products; Trehalose dihydrate, D-Galactose and Sucrose. BioSpectra is completing final commercial validation of these three products and will have them available to the market by midyear.
BioSpectra, Inc. has announced the successful launch of its new ISO Class 6 manufacturing suite for the production of Sodium Chloride solutions.
SCHOTT Pharma Packaging division signed an exclusive cooperation and development agreement with SINCAD, a French engineering company that specializes in developing and manufacturing vision control systems.
Announcing the official launch of BioSpectra’s new GMP Sodium Hydroxide System!nnThis picture is only part of our brand new GMP Sodium Hydroxide system, capable of producing over 1.2 Million liters of high purity, low iron, low Chloride, True GMP, Sodium Hydroxide made with USP WFI Grade water at 10N, 25%, 5N, 2N and 1N strength – A unique system that produces purified NaOH WITHOUT the use of NaOH pellets.nnThis system, designed in-house by our own engineers and chemists led by our owner and President Rick Mutchler, is housed in our spacious 150,000 square foot, FDA Registered and inspected, GMP facility in Bangor PA. This facility sits on a beautiful 34 acre campus, ready for increased expansion as our business continues to grow!nnFull validation reports are being finalized in the month of June but Commercial product is already shipping at 10N strength. We are ready to begin sampling customers for 10N, 25%, 5N, 2N and 1N NaOH product.