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About Palbociclib API

Product
  • Therapeutic CategoryAnti-Câncer / Oncologia

  • API Technology

    Synthetic

  • Dose Form

    Capsule/ Tablet, Oral Solids

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    Brazil DMF, USDMF, Singapore DMF

Mechanism of Action

It is a selective inhibitor of the cyclin-dependent kinases CDK4 and CDK6.

Indication

IBRANCE is a kinase inhibitor indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:

  • An aromatase inhibitor as initial endocrine based therapy in postmenopausal women; or
  • Fulvestrant in women with disease progression following endocrine therapy.

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 Palbociclib 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 Palbociclib 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.

RFQ Form

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Related Resources

Description not provided

FAQs

What is Palbociclib API used for?
  • Treats HR-positive, HER2-negative advanced or metastatic breast cancer.

What is the dosage form and strength currently available for Palbociclib?
  • Available as oral tablets: 75 mg, 100 mg, 125 mg.

How do you store Palbociclib API?
  • Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F).

Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.