USFDA

Alembic Pharmaceuticals Ltd. has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib Tablets in multiple strengths. This marks a significant milestone for the Indian drugmaker, granting it entry into the U.S. market for a high-value oncology medicine used in the treatment of chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia (ALL). The approval reinforces Alembic’s growing presence in complex generics and regulated markets, with the U.S.

Pharmaceutical giants Dr. Reddy’s Laboratories and Zydus Lifesciences have initiated voluntary recalls of select drug batches in the United States following notifications from the US Food and Drug Administration (USFDA). The recalls pertain to concerns over quality control and compliance with manufacturing standards, underscoring the regulator’s commitment to patient safety. Affected products include widely used generic medications distributed through multiple channels.

Biocon Pharma, a wholly owned subsidiary of Biocon Ltd., has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg. Developed in partnership with Carnegie Pharmaceuticals LLC, this generic antibacterial medication is indicated for reducing the risk of overt hepatic encephalopathy (HE) recurrence and treating irritable bowel syndrome with diarrhea (IBS-D) in adults. While the approval signifies compliance with regulatory standards, the product cannot be marketed in the U.S.

The United States Food and Drug Administration (USFDA) has directed Glenmark Pharmaceuticals, Granules India, and Zydus Lifesciences to recall certain pharmaceutical products from the US market due to quality and safety concerns. The recalls underscore the critical importance of regulatory compliance in global drug exports. While the specific products and batches vary by company, the action highlights challenges faced by Indian pharmaceutical firms operating in stringent overseas markets.

Natco Pharma has secured a crucial regulatory milestone with its Kothur manufacturing facility receiving clearance from the United States Food and Drug Administration (USFDA). This development underscores the company’s compliance with stringent international quality standards and strengthens its prospects in the highly regulated U.S. pharmaceutical market. The approval is expected to enhance Natco Pharma’s export capabilities, broaden its product pipeline, and support long-term growth.

Aurobindo Pharma, a leading Indian pharmaceutical manufacturer, has received a Form 483 from the U.S. Food and Drug Administration (USFDA) following a recent inspection of its manufacturing facility. The notice highlights areas where the facility failed to meet the FDA’s stringent compliance and quality standards, prompting the company to take corrective measures. Such observations, while not equivalent to a warning letter, can influence regulatory approvals and market perception.

Caplin Point Laboratories has received approval from the United States Food and Drug Administration (USFDA) for its Milrinone injection, a critical cardiovascular therapy used to manage heart failure and related conditions. The approval allows the Indian pharmaceutical company to market the injectable formulation in the U.S., a key market for high-value generic injectables. This milestone strengthens Caplin Point’s cardiovascular portfolio and underscores its capabilities in producing complex formulations for regulated markets.

Indian pharmaceutical major Lupin has received approval from the United States Food and Drug Administration (USFDA) to market its generic version of Risperidone injection, a treatment used for schizophrenia and bipolar disorder. The authorization allows Lupin to introduce the therapy in the U.S. market, where the drug is expected to see strong demand given rising cases of psychiatric disorders.

Alembic Pharmaceuticals has secured approval from the U.S. Food and Drug Administration (USFDA) for its Macitentan tablets, a key treatment for pulmonary arterial hypertension (PAH). This approval enables Alembic to market the drug in the highly regulated U.S. pharmaceutical market, marking a significant milestone in its international expansion strategy. Analysts note that entering the U.S. market not only diversifies revenue streams but also reinforces Alembic’s global credibility in specialty therapies.

The U.S. Food and Drug Administration (USFDA) has issued recalls for select pharmaceutical products manufactured by Glenmark, Alembic, and Sun Pharma, citing quality and compliance concerns. The recalls affect both prescription and over-the-counter medications distributed in the United States, underscoring ongoing regulatory scrutiny of Indian pharmaceutical exports. Companies have initiated voluntary recall procedures to mitigate risk and ensure consumer safety.