Sidvim LifeSciences Private Limited

Recent ANDA approvals General information Brazil: Regulatory Changes on Drug Pricing Control can Trigger Innovation The Jan Vishwas (Amendment of Provisions) Bill, 2025, and the Amendments to the Drugs and Cosmetics Act, 1940 Intellectual Property Nexus Pharmaceuticals Vs Exela Pharma Sciences Recent ANDA approvals We follow ANDA approvals. In July, a total of 79 ANDA approvals were issued, of which 12 were tentative. A tentative approval is a formal notification from the USFDA indicating that a generic drug application has met all scientific and regulatory requirements for safety, efficacy, and quality, but cannot be granted final marketing approval due to unexpired patents or market exclusivities held by the original brand-name drug. The companies that sought more than 2 ANDA approvals (including tentative) were as follows. Some of our other comments about a few ANDA approvals are listed below. General information Brazil: Regulatory Changes on Drug Pricing Control ca...

Contents Recent 505 (b) (2) Approvals General information Xspray Pharma's Regulatory Breakthrough: A New Dawn for CML Treatment and Shareholder Value Tharimmune Reports Pharmacokinetic Simulation Results for TH104 as Prophylaxis Against Respiratory Depression from Fentanyl and Ultrapotent Opioids Intellectual Property The Supreme Court of India's judgment in the Pernod Ricard India Private Limited Vs Karanveer Singh Chhabra case: Recent 505 (b) (2) Approvals We follow 505 (b) (2) approvals every month. Generally, 505(b)(2) NDAs pertain to changes in comparison to previously approved drugs, such as indication, active ingredient, fixed-combination, dosage form, route of administration, dosing regimen, strength, and formulation (not approvable under section 505(j)). For more details on 505(b)(2) FDA approvals, please visit this link. The details of July 2025, 505 (b) (2)/NDA approvals are as follows: General information Xspray Pharma's Regulatory Breakthrough: A ...

Contents DMF filings by Indian companies General information Lexaria's GLP-1 Breakthrough: A Paradigm Shift in Oral Drug Delivery and Market Leadership Potential Texas suit claims Lilly bribed providers to prescribe drugs Intellectual Property L'OREAL Vs Henkel AG DMF filings by Indian companies We monitor DMF filings each quarter. The USFDA recently published the list of DMF filings for the second quarter of 2025. This week, we will review the DMFs filed in June 2025. A total of 107 DMFs were filed in June 2025, with 35 filed by Indian companies and 60 by Chinese companies. Not many Indian companies are at the top of the DMF filing list. Chinese companies have long overtaken Indian companies in the DMF filing race. Now, Chinese companies consistently file more DMFs than Indian companies each quarter. Below are some of our other observations about DMFs filed by Indian companies. General information Lexaria's GLP-1 Breakthrough: A Paradigm Shift in Oral Drug Deliver...

Contents DMF filings by Indian companies General information The Central Drugs Standard Control Organisation(CDSCO) issued a circular for Nitrosamines in Ranitidine Novo Nordisk files 14 new lawsuits against unapproved semaglutide drugs Intellectual Property                F-Hoffmann-La Roche AG Vs Zydus Lifesciences Limited- Delhi High Court DMF filings by Indian companies We monitor DMF filings each quarter. The USFDA recently published the list of DMF filings for the second quarter of 2025. This week, we will review the DMFs filed in May 2025. A total of 82 DMFs were filed in May 2025, with 29 filed by Indian companies and 41 by Chinese companies. Not many Indian companies are at the top of the DMF filing list. Chinese companies have long overtaken Indian companies in the DMF filing race. Now, Chinese companies consistently file more DMFs than Indian companies each quarter. General information The Central Drugs Standard Control ...

Contents DMF filings by Indian companies-April 2025 General information Linus Health Announces Expansion of AI-Powered Early Cognitive Decline Detection Platform FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs Intellectual Property BMS vs Zydus- Nivolumab Case DMF filings by Indian companies- April 2025 We monitor DMF filings each quarter. The USFDA recently published the list of DMF filings for the second quarter of 2025. This week, we will review the DMFs filed in April 2025. A total of 89 DMFs were filed in April 2025, with 32 filed by Indian companies and 37 by Chinese companies. Not many Indian companies are at the top of the DMF filing list. Chinese companies have long overtaken Indian companies in the DMF filing race. Now, Chinese companies consistently file more DMFs than Indian companies each quarter. Below are some of our other observations about DMFs filed by Indian companies. General information Linus Health Announces Expansion...