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APIs (active pharmaceutical ingredients)

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GDUFA II negotiations: CMOs to pay one third of facility fees

29-Sep-2016 - The Pharma & Biopharma Outsourcing Association (PBOA) has helped negotiate reduced fees for CMOs in the FDA’s proposed reauthorisation of the Generic Drug User Fee Amendment (GDUFA).

AbbVie API plant opens in Singapore as first part of larger $320m site

29-Sep-2016 - AbbVie has opened an oncology and women’s health API plant, part of its planned 120,000m2 small and large molecule manufacturing site in Singapore.

US FDA: Cheng Fong Chemical must do more to investigate complaints

28-Sep-2016 - Cheng Fong Chemical has addressed problems at its Taoyuan City plant but still needs to identify the source of foreign matter found in its APIs according to the US FDA.

China made APIs shipped to fake Viagra lab via UK say Polish police

28-Sep-2016 - Viagra counterfeiters in Poland imported APIs made in China via the UK, Greece and Romania according to police who shut down a major manufacturing operation last week.

Moody's maintains B1 rating of merger-bound Avantor

27-Sep-2016 - Avantor Performance Materials has had its positive rating reiterated by Moody’s just days before its merger with Nusil Technology is expected to complete.

Cambrex bolstering API services through $25m PharmaCore acquisition

26-Sep-2016 - Cambrex will acquire clinical-scale API maker PharmaCore for $25m adding a standalone GMP facility in North Carolina approved to make Schedule II to V products.

DSP: Pharmas must be open about API suppliers to fight antibiotic resistance

26-Sep-2016 - Drug companies need to me more open about their API suppliers to help fight the spread of antimicrobial resistance (AMR) according to DSM Sinochem Pharmaceuticals.

Moderna to spend $110m on mRNA therapeutics manufacturing plant

21-Sep-2016 - Moderna Therapeutics has announced plans for a $110m (€98m) API manufacturing facility for its pipeline of mRNA therapeutics.

US FDA warns API firm Hebei Yuxing Bio-Engineering

21-Sep-2016 - Banned API firm Hebei Yuxing Bio-Engineering has had a microbial contamination problem at its plant since 2013 according to the US FDA.

Johnson Matthey's refurbished Annan API plant passes MHRA GMP inspection

20-Sep-2016 - The UK MHRA has awarded Johnson Matthey’s API facility in Scotland a GMP certificate.

Court rules in favour of Zydus' copy of Shire's controlled-release UC drug

19-Sep-2016 - Shire says it will appeal a decision invalidating a patent surrounding the controlled-release composition of its ulcerative colitis drug Lialda (mesalazine).

Bayer committed to pharma R&D and CapEx despite planned Monsanto buy

15-Sep-2016 - Bayer has said it will not cut drug R&D or manufacturing investment as a result of its planned acquisition of Monsanto.

Saneca investing €3.5m into small-scale API capabilities

15-Sep-2016 - Saneca Pharma says the expanded capabilities will feed demand for small-scale API batches to support clients’ R&D projects.

Indoco Remedies stresses that Form 483s are not data integrity related

14-Sep-2016 - Indoco Remedies says problems the US FDA identified at an ophthalmic and injectable drug plant in Goa, India last month are “correctable.”

Spain's Idifarma bolstered by investment from API maker Suanfarma

12-Sep-2016 - Spanish API maker Suanfarma has acquired a stake in contract manufacturer and spray-drying specialist Idifarma, boosting its international presence.

Cambrex investment continues as industry trends ‘remain favorable’

07-Sep-2016 - The latest in a series of investments, Cambrex has recently expanded its Sweden-based site as part of its ongoing investment in small molecule API manufacturing across its global network of facilities. 

AMRI expects to make layoffs during Euticals integration

07-Sep-2016 - AMRI has said integrating recent Italian acquisition Prime European Therapeuticals, also known as Euticals, will involve layoffs.

Avara to buy ex Crestor API plant from AstraZeneca

07-Sep-2016 - Avara Pharmaceutical Services will buy the UK manufacturing facility at which AstraZeneca made the API for Crestor and Seroquel.

More Cambrex capacity expansion: API firm to grow Karlskoga facility

07-Sep-2016 - Cambrex will spend $9m (€8m) to add large-scale manufacturing capability at its API production facility in Karlskoga, Sweden.

Bioavailability boost: Capsugel to up micronization offering at US site

07-Sep-2016 - Capsugel plans to up micronisation capacity at Quakertown, Pennsylvania facility to provide API processing services for clinical candidates and commercial drugs.

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