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APIs (active pharmaceutical ingredients)

News headlines

US FDA warns CordenPharma about Italian antibiotic API and cancer injectables plant

30-May-2016 - The US FDA was warned CordenPharma about manufacturing operations at a plant in Italy that was approved to make injectable cancer drugs last year.

Xellia starts work on testing lab at Hungary API plant citing growing demand

26-May-2016 - Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.

Novo Nordisk and Sanofi diabetes combo drugs receive US recommendation

26-May-2016 - The US FDA has voted in favour of two combination type 2 diabetes drugs putting Novo Nordisk and Sanofi head-to-head in a crowded market.

Drugs tracked in Ongar: Selcia opens radiolabelled API plant

25-May-2016 - Selcia has opened a production facility for 14C radiolabelled drug ingredients in the UK citing growing demand from CROs and sponsors running first-in-man studies.

Mock sheets and lack of stability data: US FDA hits two API makers with warnings

25-May-2016 - The US FDA has issued warning letters to two API makers found to have deviated from cGMP: Germany’s BBT Biotech and China’s Tai Heng Industry.

Croatia's Halmed finds GMP deficiencies at Dhanuka Labs' antibiotic API plant

25-May-2016 - An API plant operated by Dhanuka Laboratories does not comply with good manufacturing practices according to Croatian regulators.

Olon SpA to buy Infa Group

23-May-2016 - Italian API firm Olon SpA has signed a definitive agreement to buy Infa Group in a deal designed to strengthen its portfolio.

IMA: Angina drug API firm JP Laboratories cannot keep Daund plant up to code

23-May-2016 - Indian API maker JP Laboratories is unable to sustain GMP compliance at its facility in Daund, Maharashtra according to the Italian Medicines Agency (IMA).

Italian regulator slams simvastatin-maker Krebs for GMP deviations

23-May-2016 - APIs made by Krebs Biochemicals and Industries at its facility in Visakhapatnam, India pose a ‘critical risk’ to public health according to Italian regulators.

Saneca-owned generics firm Suir Pharma will sack 130 staff says liquidator

18-May-2016 - Suir Pharma is set to close or be sold with the loss of 130 jobs less than a year after it was acquired by Slovakian API manufacturer Saneca Pharmaceuticals.

Fermion invests $33m to add HPAPI capacity at Hanko plant

17-May-2016 - Fermion will invest €30m ($33m) to expand its API facility in Hanko, Finland to build its high potency drug ingredient manufacturing business.

Fosun Pharmaceutical confirms bid for India’s Gland Pharma

17-May-2016 - Shanghai Fosun Pharmaceutical has confirmed it made a takeover bid for Indian sterile injectable drug firm Gland Pharma.

AMRI acquires API business, expands into Europe

05-May-2016 - AMRI has acquired the Italy-based chemical company, Euticals, in a move that expands its API development and manufacturing business.

update

EDQM: Harmonized generic drug reviews would help regulators, pharmas and patients

03-May-2016 - Increased use of generics has put pressure on drug reviewers according to the EDQM which has called for more cross border collaboration and harmonization of regulations.

Codexis completes transfer of protein engineering tech to US GSK site

03-May-2016 - Codexis has completed the transfer of its protein engineering platform to a GSK earning it a $7.5m milestone payment.

Cambrex: delayed API plant opening set for Q2 opening

02-May-2016 - An API facility Cambrex is setting up in Charles City, Iowa will be operational later than planned due to delayed equipment deliveries and installation challenges.

Uninvestigated complaints of APIs containing 'filth' land Polydrug with FDA warning

28-Apr-2016 - Indian firm Polydrug Laboratories failed to investigate complaints about APIs containing foreign bodies including hairs and insects, the US FDA says in a Warning Letter.

Wuxi sets up drug supplier network to ease pharma sourcing

27-Apr-2016 - WuxI AppTec has a chemical trading network designed to help drug manufacturers source more efficiently.

Zurampic license will see AstraZeneca supply Ironwood

27-Apr-2016 - AstraZeneca will supply Ironwood Pharmaceuticals with the API and finished dosage form of the gout drug Zurampic under the licensing deal agreed this week.

Novartis aims to save $1bn by 2020 with integrated manufacturing plan

26-Apr-2016 - The savings will come from centralising manufacturing services and will complement the firm’s cost-saving business division launched last year.

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