Qualtra Pharmaceuticals Pvt Ltd | Allopathic Drug Manufacturing | GMP WHO approved

Business Model

The recent rise of specialty pharma is attributed to its flexible, versatile, and open business model while the traditional big pharma is facing a challenging time with patent cliff, generic threat, and low research and development (R&D) productivity. These multinational pharmaceutical companies, facing a difficult time, have been systematically externalizing R&D and some even establish their own corporate venture capital so as to diversify with more shots on goal, with the hope of achieving a higher success rate in their compound pipeline. Biologics and clinical Phase II proof-of-concept (POC) compounds are the preferred licensing and collaboration targets. Biologics enjoys a high success rate with a low generic biosimilar threat, while the need is high for clinical Phase II POC compounds, due to its high attrition/low success rate. Repurposing of big pharma leftover compounds is a popular strategy but with limitations. Most old compounds come with baggage either in lackluster clinical performance or short in patent life. Orphan drugs is another area which has gained popularity in recent years. The shorter and less costly regulatory pathway provides incentives, especially for smaller specialty pharma. Qualtra Pharmaceuticals is looking to invest medicine, including orphan drugs, that has become the growth engine in the pharmaceutical industry worldwide. Big pharma is also keen on in-licensing technology or projects from specialty pharma to extend product life cycles, in order to protect their blockbuster drug franchises. Ample opportunities exist for smaller players, even in the emerging countries, to collaborate with multinational pharmaceutical companies provided that the technology platforms or specialty medicinal products are what the big pharma wants. The understanding of intellectual properties and international drug regulations are the key for specialty pharma to have a workable strategy for product registration worldwide.

MANUFACTURING

Qualtra Pharmaceuticals has tied up with industry giants for manufacturing.We have outsourced manufacturing which has a well-planned infrastructure with dedicated and segregated blocks for General, Pencillins (BetalLactum) block in form of oral dosages-tablets, capsules & Dry Syrups augmented by world class facility for Carbepenems & Cephaslosporin for Dry Powder Injectables. The manufacturing facility is equipped with Automatic access control system at process area to ensure entry of only authorized personnel, Electronic Door Interlocking Systems at entry point of process areas to control man, material and movement supported by “Restricted Access Barrier (RABS) and having EU-14 Grade HEPA filters with 99.999% efficiency. This Hi-tech facility has been developed with automatic vial washing, sterilizing and dehydrogenating (tunnel systems), filling and stoppering, labeling with auto cartoner and WFI with latest technologies and controls to meet USP/BP/EP/JP specifications. It has dedicated ETP to treat effluent, using treated water for plantation, modular laboratory, requisite temperature conditions at warehouses for raw material and finished. It adheres to GMP and GLP and houses its state- of -the- art laboratories and most sophisticated equipments. To give unparalleled service and unsurpassed quality, all critical operations are closely monitored through online CCTV and touch free equipments used for communication by a team of quality oriented, well trained and highly qualified intellectuals. QC and microbiological labs are one of most well equipped labs in the region. The labs are equipped with Walk- in incubators, HPHV steam sterilizer make Machin Fabrik, LAF hoods, closed system make MDI for sterility testing, dedicated AHU’s for Sterility, media preparation and MLT areas with controlled temperature, instrument for non-viable particle count in the environment by AIR BORNE PARTICLE COUNTER and for measuring particulate matter in the injectable by LIQUID BORE PARTICLE COUNTER, dedicated sampling area provided for samples, dedicated walk-in Stability chambers are equipped and installed for stability test study.