IOL Chemicals and Pharmaceuticals receives approval CDE of NMPA, China for Ibuprofen
This approval authorizes the company to export Ibuprofen to the Chinese markets
This approval authorizes the company to export Ibuprofen to the Chinese markets
The inspection concluded with 6 observations and none of them were related to Data Integrity
The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K
Dasatinib Tablets is indicated for the treatment of (i) newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia
The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard
Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older
The product will be launched in Q1FY26
The company does not expect this development to have any material impact on the current business operations
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas
Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis
This approval marks a significant milestone in OneSource’s ongoing commitment to quality and regulatory compliance
Raichur site is the group’s largest API facility and part of a wider network of seven sites
The company expects to launch this product through its marketing partner in the near future
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