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AMRI licenses Teewinot's cannabinoid analytical standard production tech

22-Jun-2016 - AMRI has licensed technology needed to make an analytical standard drug firms working with cannabinoids can use for research and quality control.

Novacap subsidiary starts work on pharma-grade sodium bicarbonate plant in Singapore

21-Jun-2016 - Novacap has started building a sodium bicarbonate production facility in Singapore, citing Asian drug and food manufacturers as target customers.

Phalanx Labs banned from shipping APIs to US after refusing inspection

17-Jun-2016 - The US FDA has banned Phalanx Labs from shipping products to the US after the Indian API and intermediates firm refused to let inspectors visit its site in Visakhapatnam.

Indian drug advisory board backs proposed API import license fee hike

16-Jun-2016 - A plan to charge drug firms more to import APIs into India has won the support of the Government’s Drugs Technical Advisory Board (DTAB).


The strife of Pii: UK MHRA finds GMP deviations at two facilities

15-Jun-2016 - The UK MHRA has identified GMP deviations at two manufacturing sites operated by US firm Pharmaceutics International Inc (PII).

Nemus licenses synthetic cannabinoid production tech from Teewinot

14-Jun-2016 - Nemus Biosciences has licensed rights to an in-vitro synthetic cannabinoid manufacturing method developed by Teewinot Life Sciences.

Cristália gets ANVISA nod to make burns treatment at new biomanufacturing plant

10-Jun-2016 - Brazil’s ANVISA has cleared Cristália Laboratory to make an API for an over-the-counter (OTC) burns treatment at a recently established $40m biomanufacturing facility in Itapira, Sao Paulo.

Hovione aims to be big in Japan, citing growing demand for generic APIs

09-Jun-2016 - Hovoine has opened a sales office in Osaka, Japan citing growing demand for generic APIs and manufacturing services.

Carbogen Amcis to buy GEA plant and convert it for API production

07-Jun-2016 - Carbogen Amcis plans to buy a GEA Pharma Systems facility in Bubendorf, Switzerland to support its API and ADC businesses. 

Sun sells two more US manufacturing plants

06-Jun-2016 - Sun Pharma has agreed to sell two US oral solid dose manufacturing plants to Frontida BioPharm.

EC to reward NGOs that identify API manufacturers that pollute

06-Jun-2016 - Organisations that identify API manufacturers whose manufacturing activities spread antimicrobial resistance will be considered alongisde other NGOs for a new European Commission award.

Novasep targets US clients with new API kilo scale and synthesis lab

06-Jun-2016 - Novasep has expanded its kilogram scale fine chemical offering through a new synthesis facility at its site in Pennsylvania.

Safety shutdown at US plant hurt Johnson Matthey's API business in 2015/16

02-Jun-2016 - API revenues were held back by temporary safety shutdown at a facility in the US and lower demand for bulk opiates according to Johnson Matthey.

Megafine must investigate data faking at banned API plant says US FDA

01-Jun-2016 - The US FDA has told Megafine Pharma it must determine the extent of data falsification at the plant in Nashik, Maharashtra that was banned from shipping APIs to the US last year.

Granules 483-hit API plant receives all clear from US FDA

31-May-2016 - A Granules API plant in Hyderabad which received a Form 483 with three observations has been given the all clear by the US FDA.

Oasmia reviewing proposals from firms interested in API solubility enchancement tech

31-May-2016 - Oasmia Pharmaceutical AB has started reviewing ‘term sheets’ from firms interested in its vitamin A-derived drug delivery tech.

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.

Colorcon to buy BASF's Kollicoat coating system product

25-May-2016 - Colorcon will buy BASF’s Kollicoat excipient coating system product line in a deal announced today.

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.

Ajinomoto Althea gets US patent for fast, industrial-scale antibody crystallization method

19-May-2016 - Ajinomoto Althea has been granted a US patent for a whole antibody crystallization method that is faster at producing stable, biologically-active crystals than current techniques.

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