The Indian government seeks to boost local drug production by stipulating that the ‘local content’ of domestic products is 75% and 10% for those that are non-domestic.
Roquette has purchased a majority stake in excipient manufacturer Crest Cellose, in an aim to increase its footprint in India’s generic pharmaceutical market.
Dr. Reddy’s Laboratories site in Visakhapatnam, India, was issued a Form 483 last month, yet shares rose after a more recent audit where zero observations were noted.
India-headquartered Glenmark Pharmaceuticals has opened a 100,000-square-foot facility on the East Coast for the manufacture of fixed dose formulations.
The FDA’s recent guidance on complex generics ‘increases clarity’ for Indian drugmakers targeting the US market, according to India Ratings and Research.
The US FDA’s inspection of Lupin gave its manufacturing process for its ‘sartan’ products the all clear but managed to find one “procedural deficiency”.
Apotex had seemed to be having a good week after it received US FDA approval for its generic product, only for it to then be on the receiving end of a warning letter the following day.
Novo Nordisk announced a distribution agreement that will see quats delivered by Signet to the healthcare industry in India, as well as Bangladesh and Sri Lanka.
ACG has expanded its capabilities by completing its work on a lamination facility to be able to complete all packaging requirements for solid oral medication in-house.
Drug firms that want to trial or sell vaccines in India, or import them into the country, will need to seek CDSCO permission via an online portal from now on.
Recipham has agreed to pay the founders of Nitin Lifescience Limited INR2.8bn ($44m) for the remaining 26% stake they own in the India-based drug manufacturer.
The pharma world has converged in Frankfurt, Germany for this year’s CPhI Worldwide. In-Pharmatechnologist is here too to report the latest trends affecting the industry.
Baxter International has agreed to pay Claris Lifesciences $625m (€598m) for three manufacturing facilities and a portfolio of 11 approved injectable drugs.
With no active production at the plant since 2013, the company said it would shutter its Mumbai, India-based facility in mid-September, according to a Bombay Stock Exchange filing.
The Indian Government wants to build API production capacity and revive state run manufacturer Hindustan Antibiotics to cut reliance on Chinese imports.
Cultural differences and broken promises are behind Indian GMP failures and acute generics shortages in the UK, according to one pharmaceutical distributor.
The Indian Government has accused the authors of a paper analysing the quality of drugs sold in Africa of leading an attack on the Indian drug industry, but researcher Roger Bate says they are “shooting the messenger.”
Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.
Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.
Quality and IP issues are driving firms back to the US and Europe for their contract manufacturing according to experts, but Kemwell says there are still opportunities for Indian CMOs.
The Indian Supreme Court has been asked to cancel Ranbaxy’s manufacturing license in the wake of quality problems that earned the firm a US import ban.
In a conference call Friday, FDA Commissioner Margaret Hamburg explained the importance of her recent trip to India, calling for more harmonization between the regulators.
US Food and Drug Administration Commissioner Margaret Hamburg will travel to India from February 10-18 to strengthen the agency’s cooperation with Indian regulators at a time when India needs some direction.
Aurobindo has denied reports of a boiler blast at an Andhra Pradesh, India facility whilst Amgen is investigating an incident at its San Francisco R&D site.
As questions continue to be raised over the policies governing clinical trials in India, new regulations and amendments to the country's pharmaceutical laws are now coming to light.
Wockhardt remains confident its troubled manufacturing facility in India will be back up and running in three months after receiving a certificate of non-compliance from the MHRA.
Indian drug manufacturers have 18 months to test drugs not approved by India’s Central Drugs Standard Control Organization (CDSCO) for efficacy and safety or they will be pulled from the market.
