Olaparib- GRAND WUYAO (JIANGSU) PHARMACEUTICAL CO., LTD

GRAND WUYAO (JIANGSU) PHARMACEUTICAL CO., LTD

Business Type:Manufacturer

Country/Region:China

Ddu Verified

HOT Rank

8/10

Basic Information

Structural Characteristics

Chemical Structure: A poly(ADP-ribose) polymerase (PARP) inhibitor, featuring a phthalazine core linked to a piperidinyl-pyrimidine moiety.
Mechanism of Action: Inhibits PARP1/2 enzymes, disrupting DNA repair in tumor cells with homologous recombination deficiencies (e.g., BRCA-mutated cancers), leading to synthetic lethality.

Pharmacological Properties

Therapeutic Use:
- Indicated for:
  - Ovarian cancer (advanced, recurrent, BRCA-mutated).
  - Breast cancer (hereditary, BRCA-mutated, HER2-negative).
  - Prostate cancer (metastatic, homologous recombination repair-deficient).
  - Pancreatic cancer (BRCA-mutated, advanced).
Route of Administration: Oral administration (tablets/capsules).
Pharmacokinetics:
- Moderately absorbed, with peak plasma concentration reached in 1–3 hours.
- Metabolized primarily by CYP3A4/5; excreted in feces (77%) and urine (14%).

Standards and Specifications

Pharmacopoeia Compliance: Meets USP, EP, ChP, and other major pharmacopoeial standards.
Key Quality Indicators:
- Purity: ≥99.0% (HPLC).
- Related Substances: Strict control of impurities (e.g., desmethyl olaparib, oxidative products).
- Residual Solvents (e.g., ethanol, dichloromethane), Heavy Metals, Moisture Content, and Microbiological Tests.

Storage and Handling

Storage Conditions: Store in a dry, sealed container at room temperature (10–30°C), protected from light and moisture.