Alembic Pharmaceuticals (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Binimetinib Tablets, 45 mg. Alembic had previously received tentative approval for Binimetinib Tablets, 15mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Mektovi Tablets, 15 mg of Array.
Binimetinib is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. It is also indicated, in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.
Amber Group has entered into a manufacturing collaboration with Oppo Mobiles India (Oppo India). OPPO India is a licensed manufacturer of Mobile Phones for brands of OPPO, OnePlus and Realme (the Brands) in India.
Under this collaboration, Amber Group will manufacture Mobile Phones for the Brands, combining the Brands' global product expertise with the Indian partner's manufacturing scale, operational capabilities, capability to enhance local value addition and local supply chain strengths.
This partnership reflects OPPO India's recognition of Amber Group's capabilities to deliver quality, scale, and consistency. For Amber group, the collaboration represents an important milestone in its efforts to expand its role in manufacturing and strengthen its long-term growth platform.