About Posaconazole API
Therapeutic CategoryAnti-Infeccioso
API Technology
Synthetic
Dose Form
Suspension, Tablets, Delayed released tablets and solution
Dr Reddy's Development Status
Available (Commercial)
Available Regulatory Filing
USDMF
Mechanism of Action
Posaconazole blocks the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450 dependent enzyme lanosterol 14α-demethylase responsible for the conversion of lanosterol to ergosterol in the fungal cell membrane. This results in an accumulation of methylated sterol precursors and a depletion of ergosterol within the cell membrane thus weakening the structure and function of the fungal cell membrane. This may be responsible for the antifungal activity of posaconazole.
Indication
Noxafil is an azole antifungal agent indicated for: injection, delayed-release tablets, and oral suspension
- Prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as HSCT recipients with GVHD or those with hematologic malignancies with prolonged neutropenia from chemotherapy. Oral suspension
- Treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole.
Dr. Reddy's Expertise
Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Posaconazole API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.
Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Posaconazole API is the outcome of the extensive expertise in R&D, IP, and Regulatory.
A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.
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