Active Pharmaceutical Ingredients - Dr Reddy's
Active Pharmaceutical Ingredients - Dr Reddy's

About Niraparib Tosylate API

Product
  • Therapeutic Category 抗がん/腫瘍

  • CAS Number

    1613220-15-7

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available

Mechanism of Action

Niraparib works by blocking the activity of PARP enzymes, which leads to the accumulation of DNA damage and ultimately cell death in cancer cells. This mechanism of action is thought to be particularly effective in cancer cells that have deficiencies in homologous recombination DNA repair, such as those with mutations in the BRCA1 or BRCA2 genes.

Niraparib is indicated for the treatment of ovarian cancer, specifically in patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. The medication is used as a maintenance treatment and is taken orally in tablet form.

Indication

Niraparib (brand name Zejula) is a medication that is indicated for the treatment of ovarian cancer. Specifically, it is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapeutic regimens and who have a deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) tumor.

Niraparib is a poly ADP ribose polymerase (PARP) inhibitor, which works by blocking the activity of PARP enzymes in cancer cells. This leads to the accumulation of DNA damage and ultimately cell death in cancer cells. The mechanism of action is thought to be particularly effective in cancer cells that have deficiencies in homologous recombination DNA repair, such as those with mutations in the BRCA1 or BRCA2 genes.

Niraparib is taken orally in tablet form and is used as a maintenance treatment, meaning it is taken after initial treatment with chemotherapy to help prevent the cancer from returning. The medication is used in combination with other treatments, as determined by a healthcare provider.

Dr. Reddy’sの専門知識・技術

ハイデラバード(インド)に本社を構えるDr. Reddy’s Laboratoriesは、世界的に有名な原薬(API)供給業者です。Dr. Reddy’sのAPIビジネスは米国、ヨーロッパ、ブラジル、南米、日本、中国、韓国、その他の新興市場において製薬会社の推奨パートナーとなっています。

Dr. Reddy’sのAPIビジネスは、ステロイド、ペプチド、複合長鎖分子、高薬理活性API(HPAPI /腫瘍学薬)など、複合APIの開発・製造において、30年以上にわたり高度な技術的実績を築き上げ、成長しています。この専門知識・技術は弊社の知的財産および規制関連業務の実績と共に、一貫して規制基準を満たし、それを超える優れた価値を生み出しています。Dr. Reddyの(-) API, R&D (研究開発)、IP、規制の高度な専門知識・技能の結果です。

顧客が真っ先に市場に参入するのに重要な要素は、機敏な供給網です。弊社は全施設を効率的に、そしてコストを最適化して稼働させ、品質と安全性、また、生産性の最新基準に従うことで、そうした供給網を実現させます。オフィスと工場の結びつきを強化し、ダイナミックな市場の変化に迅速に対応しています。そうした理由から、弊社は不足を解消して突発的な供給を満たすことができるのです。

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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.