Upcoming ANDA Filings The Research & Development team recently initiated demonstration batches for oral liquid drug products in final stages of preparation for upcoming ANDA filings. Bid Completion WDPrx completes multiple bids for new OTC and prescription manufacturing distribution opportunities. Formulation Finalized WDPrx finalizes the unique formulation of an OTC drug product for a national pharmaceutical distributor. Order Fulfillment for Prominent Drug Distributor Packaging Technician Elizabeth Duarte maneuvers a pallet of finished goods to the dock for immediate shipment to a na ..read more

In-Person Trade Event with WDPrx Angela Holley, Director of Business Development at WDPrx, attended the ECRM trade show in Denver, Colorado to promote WDPrx development and manufacturing capabilities to representatives of branded pharmaceutical manufacturers. Successful Audit Completion WDPrx successfully completed a quality audit to qualify the facility as a co-manufacturer for a large OTC product with national retail distribution. Research and Development Testing WDPrx completes R&D batches and conducts analytical testing for a new product from a large health supplement manufacturer ..read more

Additional Services WDPrx performs analytical lab services to assist clients in saving time and costs compared to using outside labs.  A client recently had requested micro testing and an accelerated stability study for their upcoming launch. New Product for Commercial Launch WDPrx manufactures, packages and serializes commercial launch batches for a new ANDA product that recently received FDA approval through our Houston manufacturing facility. Remaining Stocked During Pandemic Shortages WDPrx continues to receive steady, monthly supply of bottles and caps despite shortages due to the ..read more

Meeting Order Requirements on Time WDPrx worked quickly to complete manufacturing of an OTC product using our specialty, small-fill packaging equipment to meet rapidly increasing demand. Despite longer lead times for bottles and caps amidst the pandemic, WDPrx secured all components and delivered finished goods before a backorder occurred. Increasing Demand for Over-the-Counter Medications WDPrx expects to receive sizable purchase orders from a large wholesaler for manufacturing of an OTC Monograph item that will be sold in unit dose by a large market player. Expanding Manufacturing Activiti ..read more

Purified Water Supports High Quality Manufacturing  USP Purified Water is a crucial element in the manufacturing of pharmaceutical products. WDPrx operates a highly efficient, centralized water purification system that outputs 25-30 gallons per minute of Purified Water, USP producing  non-sterile oral solutions, liquid solutions, suspensions and semi-solids. Pandemic Resilience   WDPrx enables clients to overcome supply chain shortages due to Covid-19. With numerous shortages interrupting the critical supply chain to deliver important medications, we stepped in to identify ..read more

Progress and performance are daily requirements at WDPrx and our news highlights from August demonstrate our dedication to client satisfaction. TECH TRANSFERS SUPPORTED BY PLACEBOS WDPrx worked with multiple clients to manufacture demonstration and placebo batches to support tech transfers of prescription drug products in the liquid market category. PRESCRIPTION/OTC INITIATIVES   Despite supply chain challenges due to pandemic uncertainty, WDSrx completed research, development and component sourcing of several prescription and OTC monograph compliant products. Serialization And DSCSA Co ..read more

Producing quality semi-solids literally boils down to five key physical characteristics: homogeneity, particle distribution, spreadability, grittiness and use of surfactants. If one element fails, then the entire process breaks down. Each element must be closely monitored from beginning to end and after sale to assure patients receive the correct medication in the specified concentration throughout the life of the product. Pharmaceutical manufacturing of quality semi-solid products involves specialized homogenization requirements.  Homogeneity is the state of being all of one kind. For ma ..read more

WDPrx – Woodfield Pharmaceutical, LLC is a proven and reliable CMO pharma partner specializing in oral solutions, liquid solutions, suspensions and semi-solids. We increase efficiency ‘from lab to launch’ managing early stage development, R+D, technology transfer, pharmaceutical formulation and development, exhibit batches, ANDA and NDA regulatory support.   Packaging and labeling equipment is programmed to print and read 2D barcodes. Serialization Accomplished The requirements for pharmaceutical serialization compliance were completed at WDPrx last year with time to spare before the FD ..read more

Although they appear as synonyms in the thesaurus, the words ‘cost’ and ‘expense’ have two different meanings when referring to technology transfer in pharmaceutical contract manufacturing. A technology transfer is the process of changing manufacturers of a pharmaceutical drug product.  The pharmaceutical outsourcing procedure involves thorough analysis of every phase of the current manufacturing process from raw materials sourcing and process requirements to equipment specifications and production methods. Among factors affecting successful technology transfer that must be assessed at th ..read more

The relationship between pharmaceutical manufacturers and their contract manufacturing organizations is a key factor determining successful outcomes. Several important areas should be considered during project negotiations between manufacturers and their CMO partners to maintain productive relationships that maximize positive results.  These categories include dispute resolution, division of responsibilities, changes requested outside the agreement terms, regulatory compliance filing requirements, logistics capabilities and business practices. DISPUTE RESOLUTION C ..read more