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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.

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The rise of Fixed-Dose Combinations (FDCs): What it means for pharma players

Express Pharma

Fixed-dose combinations (FDCs), which contain two or more active ingredients in a single dosage form, have seen a significant rise in production and usage across the pharmaceutical industry.

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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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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: 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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Shaping the future of India’s pharmaceutical operations

Express Pharma

Over the past decade and more, Indias pharmaceutical sector has become the worlds largest supplier of generic medicines, with exports growing faster than the global average. The industry is at a tipping point, however: the Indian and global landscapes are shifting.

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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.

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