Biocon says it has won EMA manufacturing approval for a $275 million plant in Malaysia where it will make insulin for export to the EU.

China’s 3SBio, in a joint venture with CPE Funds, seeks to buy Canadian CDMO Therapure Biomanufacturing for $290 million pending shareholder approval.

After issuing a warning letter to India’s Mahendra Chemicals, the agency has followed up by putting its API operation after finding a data and document…

The FDA has taken a close look at Hetero Labs' finished products plant in Telangana, India, and decided it didn't like what it found.

Samsung inked a novel drug R&D pact with Takeda, GSK China partnered with Alibaba on HPV vaccination, Gland is revising its M&A deal with Fosun.

India-based Alembic Pharmaceuticals is selling its formulation manufacturing plant in Baddi to Scott Edil Pharmacia for an undisclosed amount.

A fire disrupted production last week at an Algerian-based generics plant, according to Indian drugmaker Alembic Pharma.

Sun Pharma has been stung by a decade-old pay-for-delay lawsuit, one of a of a host of issues that contributed to a 74% profit slide.

Sun's quarterly U.S. sales dropped 42%, BeiGene offers a public offering of $175 million and the FDA sent a Form 483 to Biocon.

The Biocon sterile manufacturing plant that got spanked by European and FDA regulators earlier this year has taken another whipping by the FDA.