• Indian API Manufacturer Accused of Fabricating Manufacturing, Quality Data

    The US Food and Drug Administration (FDA) has sent yet another letter to an India-based pharmaceutical manufacturer alleging inadequate controls to prevent the falsification of testing data-at least the ninth such letter sent in the last year. Background As Regulatory Focus has previously explained, FDA has been in the midst of a crackdown against deficient manufacturing practices in India, where inspectors have discovered glaring problems and even outright fraud. Si...
  • FDA Finds 'Significant' Problems at API Manufacturer

    Two facilities maintained and run by a manufacturer of active pharmaceutical ingredients (API) exhibited serious violations of current good manufacturing practices (CGMPs), the US Food and Drug Administration (FDA) said in a Warning Letter issued this week . The API manufacturer, CBS Chem , was subject to two separate inspections in 2013, one for its facility in Tempe, AZ and another for its Tuen Min, Hong Kong facility. Arizona While FDA inspectors alleged that both...
  • Brazil Opens Consultation on API Manufacturing Change Notifications

    Brazil's National Agency for Sanitary Surveillance (Anvisa) opened a public consultation (Consultation No. 22/13) on 12 July 2013 concerning new requirements for reporting manufacturing changes for active pharmaceutical ingredients (APIs). The proposal provides a classification system as to the types of possible changes and the reporting procedures that should be adopted in each case. The manufacturer would have to notify Anvisa of changes according to the impact on t...
  • India to Require Notification of Foreign Drug Import Alerts

    Indian pharmaceutical companies will now be required to inform the Central Drugs Standard Control Organization (CDSCO) about any drug import alert restrictions imposed on their products by foreign regulatory authorities, according to a new notice issued on 26 June 2013 by the Drugs Controlled General of India (DCGI). The notice highlights the fact that local manufacturers whose drugs are the subject of foreign regulatory action also supply the same or similar drugs on ...
  • Mexico Amends API Manufacturing Regulations to Meet EU Requirements

    • 01 July 2013
    Mexico's Ministry of Health, through the Federal Commission for Protection against Health Risks (COFEPRIS), has updated the country's requirements on Good Manufacturing Practices (GMPs) for active pharmaceutical ingredients (APIs) comparable to those issued by the European Union. The new GMP requirements come into force immediately and are mandatory for all establishments engaged in the manufacture and distribution of APIs. With this standard, Mexico believes that i...
  • India's List of API Manufacturers Confirmed for Export to EU

    India's Central Drugs Standard Control Organization (CDSCO) has posted a List of Written Confirmations Granted that sets forth 57 active pharmaceutical ingredient (API) manufacturing sites in India that have been confirmed by the CDSCO as complying with the good manufacturing practice (GMP) requirements mandated by the EU for API imports as of 2 July 2013. Major API producers such as Ranbaxy, Teva, and Mylan have several sites listed, which ensures that their exports w...
  • Japan Joins Switzerland, Australia on List of Countries With API Quality Standards Equal to EU

    On 2 July 2013, new rules are set to go into effect in the European Union that radically change the process by which active pharmaceutical ingredients (APIs) manufactured outside the EU enter into the region. And while many countries are scrambling to get basic systems into place that will allow the manufacturers they regulate to meet the rules, Japan has now joined a small but elite group of nations that will be able to bypass many of the rules' most onerous provisions. ...
  • India Finalizes Guideline Meant to Bring Country into Compliance with New EU API Rules

    • 24 May 2013
    India has issued new guidelines meant to bring the country-and its significant generic pharmaceutical industry-into compliance with new EU rules requiring that active pharmaceutical ingredient exports to the region be accompanied with attestations that the products were manufactured to good manufacturing practice (GMP) standards, reports the India Times . The EU's requirements are set to come into effect on 2 July 2013, and a number of countries, including China and Bra...
  • Warning Letter to Boehringer-Ingelheim Alleges Particle Contamination, Deficient Investigations

    The US Food and Drug Administration (FDA) has released a copy of a warning letter sent last week to German pharmaceutical manufacturer Boehringer-Ingelheim, citing alleged manufacturing deficiencies found at the company's Rhein, Germany plant. The letter, sent 6 May 2013, references a November 2012 inspection at the facility, which manufactures both active pharmaceutical ingredients and finished pharmaceuticals. FDA said its inspectors observed a number of violations of ...
  • Brazil Establishes Contingency Process for Dealing With EU API Export Rules

    Under a new plan announced by Brazil's regulatory agency, Anvisa, even if Brazil fails to obtain EU recognition for its active pharmaceutical ingredient (API) good manufacturing practice (GMP) standards by the mandatory date of 2 July 2013, regulators will still provide Brazilian companies with a document indicating GMP compliance so facilitate exports of their APIs. The Falsified Medicines Directive (Directive 2011/62/EU) was adopted in May 2011 to safeguard public he...
  • Final FDA Guidance Clarifies Regulatory Classification for Novel Formulation of Pharmaceuticals

    The US Food and Drug Administration (FDA) has released a new final guidance document regarding how regulators plan to classify pharmaceutical products that are made of solid-state co-crystals, a novel formulation for drugs that raises some equally novel regulatory issues. Background Pharmaceutical products are generally comprised of two components: An active ingredient (API) and an excipient, which serves to enhance the product's qualities, including bioavailability, ta...
  • India issues revised draft guidance for API exports to EU

    On 7 March 2013, India's Central Drugs Standard Control Organization (CDSCO) issued revised draft guidance on the "Written Confirmation" procedure that must be implemented by India's exporters of Active Pharmaceutical Ingredients (API) to the European Union. The procedure will also be required to be implemented by the CDSCO, including its port offices. Under EU law, the CDSCO has been designated as the "Competent Authority" for India and is responsible for notifyi...