DeclutterPharma

The FDA issued a warning letter to Glenmark Pharmaceuticals Limited on July 11, 2025, following an inspection of their drug manufacturing facility in Pithampur, India, from February 3 to 14, 2025. The letter outlines significant violations of Current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals. As per the website information, the site capacity is as follows: Oral solid dosages: 1490 Mn tablets Immuno Suppressant Block: Capsules – 42 Mn Ointment & Creams – 80 MT Key Violations Failure to Thoroughly Investigate Discrepancies and Failures: The firm failed to adequately investigate several dissolution failures for potassium chloride extended-release (ER) capsules during stability testing. The investigation into the root causes of these failures was insufficient, particularly regarding the impact of changes in API particle size and solution content. Process changes, such as the introduction of a new component and alterations to process parameters, wer...

The FDA is investigating the root cause of benzene contamination in certain drugs and informing drug manufacturers about the risks associated with benzene contamination from drug components and other potential factors. Here's a summary of the FDA's alert to drug manufacturers regarding the risk of benzene contamination in certain drugs: Key Concerns: Benzene Contamination: The FDA is alerting drug manufacturers to the potential risk of benzene contamination in drug products. Benzene is a known human carcinogen. Root Cause Evaluation: The FDA is evaluating the root cause of benzene contamination in certain drugs and alerting drug manufacturers to the risk of benzene contamination from drug components. Recalls: Certain drug products, including hand sanitisers, benzoyl peroxide products, and aerosol drug products, have been recalled due to benzene contamination. Manufacturer Responsibilities: Testing: Drug manufacturers are required to establish scientifically sound and appr...

On 24 July, Lupin announced that it has received approval from the USFDA for its ANDA for Liraglutide Injection Single-Patient-Use Prefilled Pens and Glucagon for Injection vials. Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen is bioequivalent to Victoza® Injection, 18 mg/3 mL (6 mg/mL) of Novo Nordisk Inc. It is indicated as an adjunct to diet and exercise to improve glycemic control. Lupin stated in the press release that Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen (RLD Victoza®) had an estimated annual sale of USD 458 million in the U.S. (IQVIA MAT May 2025). There are two other approved products in the US market. Sandoz has settled the case and is likely awaiting approval from the FDA. Teva is in the market with Authorised Generics. Lupin is likely using Hybio API. Details of Lupin’s recent import are as follows. One may notice the API is being imported at USD 441/gram, and those following liraglutide API prices ca...

FDA form 483 observations: NATCO Pharma General Information: • Company: NATCO Pharma Limited, Pharma Division, Kothur Village, Rangareddy,           Telangana, India • Inspection Dates: 06/09/2025 - 06/19/2025 • Products manufactured: Sterile and Non-Sterile Drug Manufacturers   Oral solid dosages, including Cytotoxic Orals Cytotoxic Injectables Pre-filled Syringes Key Observations: 1. Environmental Monitoring Deficiencies (Observation 1): The firm's system for monitoring environmental conditions in aseptic processing areas is deficient. Electronic data for non-viable particle (NVP) counts used in environmental monitoring and cleanroom qualification is not adequately reviewed. Discrepancies exist between electronic data and official hardcopy results for NVP, affecting multiple batches between 11/02/2023 and 04/16/2024, where results were altered. Operators saved data on USB drives, potentially allowing data manipulation, which indicates a gap in dat...

On June 26, 2025, the U.S. Food and Drug Administration (FDA) finalised its long-awaited guidance, Conducting Remote Regulatory Assessments (RRA): Questions and Answers, which builds on draft guidance issued in July 2022 and again in January 2024. The document is available here . Here's a summary of the main points from the document. I. Introduction to Remote Regulatory Assessments (RRAs) Background: The FDA adapted its field activities during the COVID-19 pandemic to include remote regulatory assessments (RRAs) to ensure oversight of regulated industries while reducing the spread of the virus. RRAs are used to evaluate compliance with FDA requirements remotely. Definition: RRAs encompass various activities, including remote interactive evaluations and remote record reviews. Purpose: RRAs assess establishments, verify compliance, and support regulatory decisions. Revised Guidance: This guidance finalises a revised draft, aiming to enhance industry understanding and facilitate t...