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Indoco receives EIR for its manufacturing facility in Goa (Plant I)

Express Pharma

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.

Dosage 97
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The critical role of the generics sector during the pandemic

pharmaphorum

The generics medicines sector can, too, play a substantial part in discovering new areas for licensed products to be used in. Delivery of essential medicines. Many generic medicines are used in intensive care units globally, while others are used to treat chronic illnesses that do not go away irrespective of the pandemic.

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Only 2 per cent medicines undergo quality control checks: Former IMA President

Express Pharma

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 generic medicines, beckons for clarity.

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Complex generics: Are global regulators addressing the needs?

Quality Matters

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.

Dosage 52
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IPA questions FAERS data interpretation in the Ohio State University study

Express Pharma

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 generic medicines to the US.

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Complex generics: The need and challenges

Quality Matters

Complex generics: The need and challenges Generic medicines have benefited millions of Americans and saved trillions of dollars. Accounting for approximately 90% of prescriptions filled in the United States , generic medicines are essential to increasing patient access to important drug therapies.

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PMPRB launches consultation on revised Draft Guidelines

Pharma in Brief

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.