This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Indoco Remedies announced the receipt of an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) status from the US Food and Drug Administration (USFDA) for their facility for solid dosages (Plant I) located in Verna, Goa.
The genericsmedicines sector can, too, play a substantial part in discovering new areas for licensed products to be used in. Delivery of essential medicines. Many genericmedicines are used in intensive care units globally, while others are used to treat chronic illnesses that do not go away irrespective of the pandemic.
Krishna Sarma, Managing Partner, Corporate Law Group , said, “The entanglement of Registered Medical Practitioners (RMPs) in third-party activities involving pharmaceutical companies, coupled with the haze surrounding genericmedicines, beckons for clarity.
Complex generics: Are global regulators addressing the needs? The development of generic versions of innovator medicines is a global public health need. 1 Although CGx can add to development complexities, global regulators and standard-setting organizations can help address related challenges.
The organisation stated, PV (pharmacovigilance) events are generally a reflection of the properties of the active drug substance and the drug product, irrespective of where it is manufactured. The FDA has an established office in India overseeing the number of qualified manufacturers supplying genericmedicines to the US.
Complex generics: The need and challenges Genericmedicines have benefited millions of Americans and saved trillions of dollars. Accounting for approximately 90% of prescriptions filled in the United States , genericmedicines are essential to increasing patient access to important drug therapies.
The revised Draft Guidelines divide existing patented medicines, e. All existing patented medicines are assigned a Maximum List Price ( MLP ) tested against ex-factory list prices. Medicines falling below these thresholds, as well as biosimilars and generics, will be classified as Category II.
We organize all of the trending information in your field so you don't have to. Join 11,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content