In an extensive and enlightening chat with Prasad Raje, the CEO of LGM Pharma, OSP gained profound insights into the company's trajectory within the pharmaceutical industry.
Integrated supplier and service provider to the pharma industry, ACG, has secured a position in the World Economic Forum's prestigious community of Global Lighthouses.
At the open of the global pharmaceutical industry gathering, a survey of executives from around the globe indicates a rosy mood among professionals in the field.
Organicell has announced the initial results from its India-based trial of the COVID-19 treatment Zofin look promising, plans to expand to more patients.
The survey, unveiled ahead of next week's CPhI Festival of Pharma, reveals perspectives, concerns and future plans of more than 500 industry executives.
After the Indian government moved to limit the export of APIs, an Indian export association says fear is spreading amongst European businesses over supply.
With the supply of certain APIs limited by the spread of the virus, Indian government orders restrictions on the export of ingredients and formulations.
After an investigation last year, the FDA cites problems across multiple sites within the Lupin manufacturing network, raising questions about ‘management oversight and control’.
The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.
In a warning letter, the US FDA details how its inspectors discovered cGMP document awaiting shredding and records discarded in a 55-gallon drum at Strides’ facility.
Indoco confirms receipt of a warning letter from the US FDA and the agency posts details of a Form 483 for two different facilities in the space of one week.
Strides’ Puducherry, India, facility has received a warning letter from the US FDA, which the company announced will lead to deferrals for 10 pending ANDA approvals.
US FDA delivers a Form 483 with four observations to Sun Pharma, with one noting that the company took eight years to create design plans for the production of one product.
Aurobindo has received another Form 483 from the US FDA, after the agency found its response to complaints were ‘not always sound’ for products destined for the US market.
Heritage announces a recall of lots of amikacin sulfate injection and prochlorperazine edisylate injection, due to evidence of selected products being non-sterile.
The Indian company announced that the US FDA issued observations for both its Indrad and Dahej facilities, as well as being required to expand its losartan recall.
The USTR stated that 20% of medicines on the Indian market were counterfeit, a claim that the country’s health secretary labelled as an ‘opposition to low-cost generics.’
Teva begins recall in the US of 35 lots of losartan tablets and Torrent expands its recall to include an additional 104 lots, after trace amounts of NMBA were discovered in both companies' products.
A US trade report identified that counterfeit drugs are becoming a greater issue through illegitimate online sales, particularly in countries such as China and India.
An observation by the US FDA notes that Aurobindo had no established control procedures to monitor its manufacturing process, resulting in batches contaminated with unidentified material.
C2 Pharma acquires digoxin API product portfolio from Noblius to secure supply of the ingredient, after disruption of the supply of the API for a number of years.
There is a common and often unchallenged perception that manufacturing quality standards in pharmerging countries are worrisome, but Lee Newton of Lonza argues this is not the reality.
Akorn announces fraud case launched by Fresenius has been denied by US courts, shortly after fourth quarter financials revealed problems within its manufacturing network.
