29-Jul-2015 - Issues with batch production records at an Indian facility have landed API maker Mahendra Chemicals with a US FDA warning letter.
27-Jul-2015 - IPEC Europe has reminded drugmakers they have less than a year to risk assess all excipients used in their products under recently introduced EU rules.
22-Jul-2015 - Ethiopia will start making its own APIs in 2020 according to the Government which says local manufacture will improve access to medicines, curb sale of counterfeits and promote innovation.
22-Jul-2015 - Lonza has reported higher revenues and profits for H1 2015, but warned that the strength of the Swiss franc means its Visp facility is still finding it hard to compete.
22-Jul-2015 - Johnson Matthey saw lower demand for opiate APIs in the three months to the end of June, which offsett more solid performance by its attention deficit hyperactivity disorder (ADHD) drug actives.
22-Jul-2015 - As part of a push to bring more novel excipients to market, IPEC-Americas is calling on the FDA to create a new regulatory review process that could relieve some of the uncertainty around the use of new excipients.
20-Jul-2015 - AMRI has bought Spanish contractor Gadea Pharmaceutical Group for $174m (€160m) to add muscle to its steroid API business and sign up more customers outside the US.
20-Jul-2015 - API firms that invest in waste management find it hard to compete with those that pollute according to DSM Sinochem, which wants environmental criteria included in GMP standards for environmental and business reasons.
16-Jul-2015 - Drugmakers risk losing financial backing if they source APIs from Indian suppliers that pollute according to Nordea Asset Management's head of responsible investments, Sasja Beslik.
15-Jul-2015 - Sandoz will shutter an Indian API facility in 2016 as part of a manufacturing refocus in the region.
13-Jul-2015 - Antibiotic API makers have an obligation to ensure their activities do not spread resistance says a group that welcomed DSM-Sinochem’s commitment to environmentally-friendly production.
09-Jul-2015 - Lupin is set to acquire Russian generics maker Biocom, adding a GMP compliant facility and gaining access to the local market.
06-Jul-2015 - GSK’s HIV unit ViiV Healthcare and China-based Desano Pharmaceuticals have forged an agreement whereby Desano will manufacture the API of GSK’s HIV drug Tivicay (dolutegravir) in China.
06-Jul-2015 - A group calling for GMP assessments to consider the environmental impact of API production says pollution generated by suppliers in China is furthering the spread of resistant superbugs.
30-Jun-2015 - In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices) at all stages of the API supply chain.
29-Jun-2015 - Canada has asked importers to quarantine APIs made by India’s Polydrug Laboratories over concerns about its manufacturing plant in Ambarnath in Maharashtra.
25-Jun-2015 - API firm Saneca Pharmaceuticals has acquired struggling drug formulator Suir Pharma Ireland in a deal with former owner Mutares AG.
25-Jun-2015 - Thermo Fisher Scientific has anncouned plans to buy research chemicals firm Alfa Aesar from Johnson Matthey for £256m ($405m).
25-Jun-2015 - GSK and UK academics claim a newly identified enzyme is the missing link in the mechanism poppies use to make painkilling alkaloids like morphine and codeine and the anticancer compound noscapine.
22-Jun-2015 - Swedish scientists who developed the solubility enhancing nanotech excipient Upsalite say it can also be used to improve delayed release formulations.
22-Jun-2015 - Raffles PharmaTech has contracted ScinoPharm to make the API for a generic version of the arthritis pain drug celecoxib being developed for the US market.
17-Jun-2015 - Polydrug Laboratories chose not to log customer complaints about APIs made at its plants in Maharashtra according to Slovenian regulators.
15-Jun-2015 - South African regulators will continue to inspect all local and some international API sites despite relaxing facility assessment rules last week.
10-Jun-2015 - Crystallisation experts from across Europe will meet in France this month to share ideas and research that will shape how APIs are made in the future.
08-Jun-2015 - Johnson Matthey saw revenue from (active pharmaceutical ingredients) APIs increase in fiscal 2015 despite competition from generic manufacturers and the relocation of a key customer.