Abiraterone 500 mg tablets manufacturer: Abiraterone 500 mg tablets, a hormone treatment medication used largely to treat metastatic castration-resistant prostate cancer, are in high demand in India due to many important factors. This comprises the rising prostate cancer incidence. Prostate cancer is one of the top 10 cancers in Indian males, with improved diagnostics leading to increased detection. Hence, as the senior male population (age 60 and up) grows, so does the prevalence of prostate cancer, necessitating more abiraterone treatment. Moreover, in India, there is a constant preference for oral targeted therapy. Patients and doctors prefer oral medicine such as abiraterone over injectable treatments since they are easier to use and require fewer hospital visits.
Apart from the above, according to NCCN and ESMO recommendations, abiraterone is now a routine line of treatment for CRPC, and oncologists frequently prescribe it. Even with this government and institutional use defined, abiraterone is widely available in oncology centres and tertiary care institutions. In this, there is a huge role for the Ayushman Bharat and other schemes. Some government health schemes include anti-cancer medications like abiraterone, which increases public sector demand. Thus, in India, there is a huge demand for the abiraterone acetate tablets 500mg manufacturing services.
A complete manufacturing process in the leading abiraterone 500 mg tablets manufacturer in India
- Pre-formulation study: first we learn about abiraterone acetate’s physicochemical properties. In these activities we include solubility studies, stability testing, and compatibility with excipients.
- API and excipient sourcing: our excipients are contained in the microcrystalline cellulose, lactose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, povidone, and so on. Also, all materials are evaluated for purity and quality (according to pharmaceutical standards).
- Dispensing and weighing: now we weigh the API and excipients precisely in accordance with the batch manufacturing record (BMR).
- Dry mixing or blending: We ensure consistent distribution of the active ingredient, combining the API and excipients in a double-cone blender or high-shear mixer.
- Granulation (optional if wet granulation is utilized): To create granules, add a binding solution (such as povidone). Wet massing is followed by sizing through a screen, and granules are also dried using a fluid bed dryer (FBD).
- Milling and final blending: granules are milled into a consistent size. After that, the final blend contains lubricants such as magnesium stearate.
- Compression: as the leading abiraterone 500 mg tablets manufacturing company, we ensure the completed mixture is compressed into tablets with a tablet compression machine. Also, tablet weight, thickness, and hardness are monitored to ensure consistency.
- Quality control (in-process and final testing): In-process assessments include weight fluctuation, hardness, friability, and disintegration time. Most importantly, in the final testing, we include assay (drug content), solubility, impurity profile, microbiological limits, and stability.
- Packaging: lastly, tablets are packaged in aluminium or blister packs to protect them from moisture. In this, we have also added labeling and batch coding that are added by regulatory guidelines.
Important benefits and applications of abiraterone acetate tablets
Abiraterone acetate tablets are primarily used to treat prostate cancer. Here’s a detailed look at its advantages and applications:
- Treatment for advanced prostate cancer: Abiraterone acetate is primarily used to treat metastatic castration-resistant prostate cancer. It is also used when prostate cancer has progressed to other parts of the body and is no longer responding to conventional hormone therapy or other treatments. This abiraterone inhibits the enzyme CYP17, which is involved in the production of testosterone and other hormones. Moreover, this reduction in testosterone levels limits the growth of prostate cancer cells, which rely on these chemicals to proliferate.
- Used in conjunction with prednisone to treat hormone-sensitive prostate cancer: it is also used in conjunction with prednisone to treat hormone-sensitive prostate cancer (in which testosterone or other hormones promote cancer growth). Moreover, this combination improves cancer treatment by more efficiently targeting malignant cells.
- Delaying disease progression: Abiraterone acetate slows the course of symptoms and growth of prostate cancer, enhancing patients’ quality of life. It is especially useful for specific persons who have failed earlier treatments and are at high risk of disease progression.
- Decreases the need for chemotherapy: Abiraterone is frequently treated as an alternative to chemotherapy for patients with advanced prostate cancer, particularly those with early-stage castration-resistant prostate cancer. Along with this, it can help lessen the need for harmful chemotherapy, resulting in a higher quality of life.
- Effective in bone metastases: Abiraterone acetate can help control prostate cancer that has progressed to the bones and prevent complications caused by bone metastases, such as discomfort, fractures, or nerve compression.
Ending
At the end of this blog, we tell you that Spica Drugs has the expertise to produce and supply a top-quality range of abiraterone tablets. Hence, if you also want to work with a reliable and genuine abiraterone 500 mg tablets manufacturer in India, reach us now.
FAQs
Q. What formulations does Spica Drugs have for abiraterone?
Ans. We are a well-known manufacturer of abiraterone acetate tablets 500mg that offer film-coated tablets and tailor dosage forms with top-quality packaging to meet the needs of our clients.
Q. Do Spica Drugs offer third-party or contract manufacture of abiraterone tablets?
Ans. Yes, we provide third-party manufacturing services with full assistance, including formulation, packaging design, and regulatory documentation for home and export markets.
Contact Details
Ph: +91-8949055013 , 0172-5020013
Email: info@janusbiotech.in