India's economic engine is revving up, but navigating the global headwinds requires sharp strategy. The rupee's recent volatility against the dollar underscores the complexities facing Indian businesses, impacting everything from import-export trade to domestic inflation. This week alone, we've seen significant shifts in the IT sector, with major players announcing restructuring and a renewed focus on AI-driven solutions. Meanwhile, the burgeoning startup ecosystem continues to attract substantial funding, despite a cautious global investor sentiment. The government's recent policy announcements on infrastructure development and digitalization are poised to further shape the business landscape, creating both opportunities and challenges for entrepreneurs and established corporations alike. Understanding these market dynamics is crucial for success in today's rapidly evolving Indian economy. Stay informed with Abtak.com for the latest insights and analysis on key sectors including finance, manufacturing, and technology – empowering your business decisions in a dynamic market. Explore the complete business news section now to stay ahead of the curve.
Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation. Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi's Sarcoma, and Multiple Myeloma. Refer label for a detailed indication. Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2mg/mL) Single-Dose Vials have an estimated market size of US$ 29 million for twelve months ending March 2025 according to IQVIA. Alembic has a cumulative total of 224 ANDA approvals (201 final approvals and 23 tentative approvals) from USFDA.
Bengaluru: Alembic Pharmaceuticals, Inc., the U.S. subsidiary of Alembic Pharmaceuticals Ltd., has acquired Utility Therapeutics Ltd. ("Utility") in a $12 million deal to strengthen its presence in the U.S. market. Alembic will begin the commercialization of Utility's recently FDA approved product Pivya® (pivmethecillam) for the treatment of uncomplicated urinary tract infections. Pivya® was approved by the FDA in April 2024. Commenting on the acquisition, Mr. Pranav Amin, Managing Director of Alembic Pharmaceuticals Limited, said: "This acquisition gives us a strategic entry into the special ...Read More >
Ahmedabad -- Senores Pharmaceuticals Limited today announced that it has entered into a definitive agreement to acquire 100% equity stake in Apnar Pharma Private Limited ("Apnar Pharma"), along with the acquisition of five Abbreviated New Drug Applications (ANDAs), marking a significant milestone in Senores' growth strategy across regulated pharmaceutical markets. Apnar Pharma, incorporated on December 12, 2014, is a privately held pharmaceutical company engaged in the licensing, development, and manufacturing of generic formulations for regulated markets including the United States, the Unit ...Read More >
New Delhi, Jun 30 (PTI) Alembic Pharmaceuticals on Monday said it has received the final approval from the US health regulator for its generic Doxorubicin Hydrochloride Liposome injection in different types of cancer. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) is for Doxorubicin Hydrochloride Liposome injection of strengths 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials, Alembic Pharmaceuticals said in a statement. The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD), Doxil ...Read More >
New Delhi, Jul 3 (PTI) Alembic Pharmaceuticals on Thursday said its US arm has acquired Utility Therapeutics Ltd in a USD 12 million (over Rs 100 crore) deal to strengthen its presence in the American market. The acquisition is being done by Alembic Pharmaceuticals, Inc, the company's US subsidiary, Alembic said in a statement. Also Read | Kolkata Fatafat Result Today: Kolkata FF Result for July 03, 2025 Declared, Check Winning Numbers and Result Chart of Satta Matka-Type Lottery Game. Subsequently, Alembic will begin commercialisation of Utility's recently FDA-approved product Pivya (pivme ...Read More >
Mumbai/Naples: Lupin has taken a step forward in expanding its U.S. generics portfolio, securing regulatory progress for a key injectable product used in surgical care. Lupin has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Sugammadex Injection. The approval covers two dosage strengths -- 200 mg/2 mL and 500 mg/5 mL -- both in single-dose vial formats. The company's product has been deemed bioequivalent to Merck's Bridion injection. It is indicated for reversing neuromuscular blockade caused by rocuronium bromide and vecu ...Read More >
Chennai: The US has imposed 100 per cent duty on the import of patented pharmaceuticals and associated pharmaceutical ingredients. Generic drugs have been kept out of the duty for the time being. But, if pharma companies increasingly seek evergreening of patents, they will see fewer off-patented drugs in the pipeline. "I have determined that it is necessary and appropriate to impose a 100 percent ad valorem duty rate on the import of patented pharmaceuticals and associated pharmaceutical ingredients," US President Donald Trump was quoted in a White House release. However, generic drugs are n ...Read More >
New Delhi, Apr 7 (PTI) Aurobindo Pharma on Tuesday said it has received final approval from the US health regulator for its generic version of dapagliflozin tablets used to control blood sugar levels in people with type 2 diabetes. The final approval granted by the US Food & Drug Administration (USFDA) to manufacture and market dapagliflozin tablets is for strengths 5 mg and 10 mg, Aurobindo Pharma said in a regulatory filing. These are bioequivalent and therapeutically equivalent to the reference listed drug Farxiga tablets, 5 mg and 10 mg, of AstraZeneca AB, it added. These products will ...Read More >