About Product Details-Cinacalcet Hydrochloride API API
Therapeutic CategoryEndocrinology
API Technology
Synthetic
Dose Form
Oral Solid/Tablets
Dr Reddy's Development Status
Available (Commercial)
Available Regulatory Filing
USDMF, EUDMF, Canada DMF, Russia DMF, Brazil DMF, China DMF
Mechanism of Action
The calcium-sensing receptor on the surface of the chief cell of the parathyroid gland is the principal regulator of PTH synthesis and secretion. Cinacalcet, the active ingredient in Sensipar, directly lowers PTH levels by increasing the sensitivity of the calcium-sensing receptor to extracellular calcium. The reduction in PTH is associated with a concomitant decrease in serum calcium levels.
Indication
Sensipar is a calcium sensing receptor agonist indicated for:
- Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.
Limitations of use: Sensipar is not indicated for use in patients with CKD who are not on dialysis
- Hypercalcemia in adult patients with Parathyroid Carcinoma (PC)
- Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy
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 Cinacalcet Hydrochloride 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 Cinacalcet Hydrochloride 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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