• Regulatory NewsRegulatory News

    French Regulators Raise Serious Concerns With Indian API Manufacturer

    France’s National Agency for Medicines and Health Products Safety (ANSM) on Monday released a new statement of serious good manufacturing practice (GMP) non-compliance for India-based active pharmaceutical ingredient (API) manufacturer Nandu Chemicals Industries. In an inspection from 20 August, the French regulators uncovered significant deficiencies linked to “the vast majority of inspected areas” at Nandu’s Hubli, India site. In particular, the inspectors highli...
  • Regulatory NewsRegulatory News

    Flying Insects and Chipping Paint: FDA Warns Chinese API Manufacturer

    Two of Xinxiang Pharmaceutical’s China-based manufacturing facilities received a US Food and Drug Administration (FDA) warning letter on 19 August after FDA inspectors found drug manufacturing equipment and facilities in such a state of disrepair as to be unsalvageable. The company, which previously received a Form 483 in 2015 and was placed on the import alert list in April, was found to be using “open equipment” for the manufacture of active pharmaceutical ingredi...
  • Regulatory NewsRegulatory News

    FDA Lowers ANDA Fee Rates for 2017

    Generic drugmakers submitting abbreviated new drug applications (ANDAs) and prior approval supplements (PAS) will see their US Food and Drug Administration (FDA) fee rates drop in 2017, though all other rates, including those for drug master files (DMF) and facility fees will increase when compared to 2016. For FY 2017, the generic drug fee rates are: ANDA ($70,480, down from $76,030 in 2016 ), PAS ($35,240, down from $38,020 in 2016), DMF ($51,140, up from $42,170 in ...
  • Regulatory NewsRegulatory News

    FDA Warns GSK’s UK Site for Contamination in API Manufacturing

    The US Food and Drug Administration (FDA) on Wednesday released a warning letter for GlaxoSmithKline’s Worthing, UK-based active pharmaceutical ingredient (API) manufacturing site. The warning letter, dated 30 June, follows an eight-day inspection of the site from 2015 during which FDA uncovered GSK’s failure to prevent cross-contamination from dedicated penicillin manufacturing areas to non-dedicated areas. FDA says it documented findings of penicillin in non...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EC to Let MAHs Delegate Certain Falsified Medicines Directive Tasks to Third Parties (23 June 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EC Accepts APIs Imported, but not Manufactured, After the Expiration of a Written Confirmation The European Commission (EC) has updated its question and answer document on the importation of active pharmaceutical ingredients (APIs) for use in human medicinal products. The update adds a section clarifying EC’s position on APIs manufactured while a written confirmation was in...
  • Regulatory NewsRegulatory News

    Two Indian Contract Pharma, API Manufacturers Refuse FDA Inspections

    The US Food and Drug Administration (FDA) this week added contract manufacturer Cheryl Laboratories’ Navi Mumbai-based manufacturing facility and active pharmaceutical ingredient (API) and intermediate manufacturer Phalanx Labs’ Visakhapatnam-based site to its list of foreign firms that are banned from shipping product to the US because they refused FDA inspections. FDA’s “Red List” identifies firm(s) that have offered FDA-regulated articles for import into the US and ...
  • Regulatory NewsRegulatory News

    CDSCO Offers Risk-Based Checklist for Indian Pharma Manufacturing Inspections

    India’s Central Drugs Standards Control Organization (CDSCO) on Thursday released a new draft checklist and evaluation tool for pharmaceutical inspectors of manufacturing sites in India. The checklist and tool will help CDSCO and state inspectors understand and collaborate on which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are compliant. “The inspections are planned to be carried out jointly by the CDSCO offici...
  • Regulatory NewsRegulatory News

    FDA Warns German Contract Manufacturer Over API Stability Concerns

    The US Food and Drug Administration (FDA) has warned Baesweiler, Germany-based contract manufacturer BBT Biotech GMBH over deviations from good manufacturing practices (GMPs), including the failure to provide stability data to support expiration dates for active pharmaceutical ingredients (APIs). The warning letter, sent 16 May and released Tuesday, follows an inspection at the API manufacturing facility in May 2015 during which FDA inspectors found BBT Biotech did not p...
  • Regulatory NewsRegulatory News

    Updated: FDA Warns Banned Indian API Manufacturer Over Filth, Incomplete Complaint Records

    Mumbai-based active pharmaceutical ingredient (API) manufacturer Polydrug Laboratories is quickly turning into the poster child for how to run afoul of nearly every major pharmaceutical regulator. This week, the US Food and Drug Administration (FDA) released its warning letter for the company following an eight-day inspection in March 2015. The three major issues uncovered by FDA included the company’s failure to record or investigate quality-related customer compla...
  • Regulatory NewsRegulatory News

    EMA Clarifies How to Include API Mix Data in a Marketing Application

    API mixes, which are mixtures of one or more excipients and an active pharmaceutical ingredient, are used to improve the safety, stability or workability of an active ingredient. Some examples of commonly used excipients for these purposes include antioxidants, preservatives and diluents. EMA says it considers the mixing process "to be the first step of the manufacture of a finished product." As such, sponsors are required to submit information about the mixture just as ...
  • Regulatory NewsRegulatory News

    Seven Pharmaceutical Regulators and NIH Collaborate to Build Drug Ingredient Database

    Drug regulators from the US, Europe, Canada, France, Netherlands, Germany and Switzerland are attempting to build a database of substances used in medicinal products to ease the exchange of such information. The database, known as Global Ingredient Archival System (ginas), provides a common identifier for all APIs and provides a consistent definition of substances globally, consistent with the ISO 11238 standard . The effort, which its developers describe as similar ...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Lilly May Move API Production Outside EU Due to REACH Regulations (17 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Eli Lilly Threatens to Move API Production out of the EU in Broadside Against REACH Eli Lilly has warned it may move production of certain active pharmaceutical ingredients (APIs) out of the European Union because of REACH regulations. The production of two of Lilly’s veterinary APIs is tied to the availability of cobalt salts, something it says is becoming a “significant pr...