NATCO Pharma Ltd.

New Delhi: Natco Pharma on Thursday said the US health regulator has issued a Form 483 with seven observations after inspecting its pharma division in Hyderabad. The US Food and Drug Administration (USFDA) had conducted an inspection at the company's pharma division located in Kothur, Hyderabad, from June 9-19, 2025, Natco Pharma said in a regulatory filing. "On conclusion of the inspection, the company received seven observations in the Form-483," it said. As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Natco said it is confident that it will address the observations within the stipulated timeline and remains committed to being cGMP compliant and supplying high-quality products to its customers and patients globally.

Hyderabad: Drugmaker, Natco Pharma , Mekaguda-based Active Pharmaceutical Ingredients (API) plant has received one observation under the form 483 from the US Food and Drug Administration (FDA). In a stock exchange filing the company informed that the US Food and Drug Administration (FDA) had conducted an inspection at the API manufacturing plant located in Mekaguda, from June 9th – June 13th and on conclusion of the inspection, the Company has received one observation in the Form-483.” The Company believes that the observation is procedural in nature and is confident to address this observation comprehensively. An observation under the Form 483 is issued if the FDA observes that certain conditions may violate the Food, Drug, and Cosmetic (FD&C) Act or related laws. However the observations are early warning of potential compliance issues and allows the company to address them before further regulatory action is considered. By Online Bureau ,

India’s pharmaceutical sector is making significant strides in peptide drug development, yet it grapples with complex regulatory challenges that could impede progress. At the recent ET Pharma Biomolecule Workshop & Connect in Hyderabad, industry leaders and regulators convened to discuss these obstacles and potential solutions.   Peptide-based therapeutics, known for their structural complexity and immunogenic potential, require rigorous quality control measures. Dr. Suresh Varma Penumathsa of Biological E. Limited emphasized the importance of early-stage aggregation pattern tracking using assays like Thioflavin T to mitigate immunogenicity risks. Dr. Gopal Vaidyanathan from Natco Pharma highlighted the challenges in impurity profiling, noting that while technologies like liquid chromatography and mass spectrometry have advanced, maintaining impurity levels below 0.1% remains demanding.   The financial burden of ensuring Good Manufacturing Practice (GMP) compliance, especially for drugs like GLP-1 with longer amino acid chains, is substantial. Dr. Vaidyanathan pointed out that re-qualification of peptides is not feasible, adding to the complexity. Dr. Manoj Metta of the US Pharmacopeia noted that despite guidelines from agencies like the FDA and EMA, the regulatory landscape for peptides remains intricate.   As India aims to expand its presence in the global peptide market, addressing these regulatory and manufacturing challenges is crucial. The country’s ability to navigate this complex landscape will determine its success in this burgeoning sector.