Indian generic giant Sun Pharma says the US FDA has flagged up new potential violations of good manufacturing practices at the company's key Halol factory, which exports a large number of products to the crucial US market and had been expected to overcome its past compliance problems.
Sun Pharmaceutical Industries Ltd.'s shares had been rising on investor optimism that US Food and Drug Administration inspectors would give the all-clear to the company’s flagship Halol plant after their visit last month to the factory, located in India's western Gujarat state.
But instead the FDA team found new potential breaches of good manufacturing practices at Halol, Sun Pharma disclosed Dec. 7...
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
Drugs in specific categories that have passed regulatory muster in certain advanced markets, including the US and Japan, will be eligible for trial waivers in India, raising sponsors’ hopes for an accelerated and more streamlined approval process in the country.
Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.
India’s drugs regulator sets out plans for extensive digitization across the regulatory value chain and regulatory rationalization initiatives, while also “looking inward” to up its game as it tightens processes and enforcement. Audit action under the revised GMP norms is also being kicked off.
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
