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'Rough notes' and backdated signatures land Indian API maker US FDA warning

29-Jul-2015 - Issues with batch production records at an Indian facility have landed API maker Mahendra Chemicals with a US FDA warning letter.

Less than a year to risk assess excipients: IPEC Europe develops 'how to' guide

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.

Ethiopia: GMP compliant local drug and API sector would yield health and economic benefits

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.

Lonza: global hedge helped offset currency exposure but Visp still a risk

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.

Johnson Matthey’s API business flat in Q1 on timing of opiate API orders

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.

IPEC calls on FDA to establish new review process for novel excipients

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.

Gadea's steroid intermediates biz means AMRI not reliant on Asian suppliers say execs

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.

Green GMP criteria would help responsible API firms compete with polluters says DSM Sinochem

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.

Nordea mulling holdings in drugmakers that source APIs from water polluters

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.

Sandoz closing Mumbai API plant but says it remains committed to India

15-Jul-2015 - Sandoz will shutter an Indian API facility in 2016 as part of a manufacturing refocus in the region.

Environmental group welcomes DSM-Sinochem and GSK efforts to halt spread of antibiotic resistance

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.

Lupin enters Russian market through Biocom deal

09-Jul-2015 - Lupin is set to acquire Russian generics maker Biocom, adding a GMP compliant facility and gaining access to the local market.

GSK back in China via new API manufacturing agreement with Desano

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.

GMP assessments should consider environmental impact say campaigners

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.

ICH clarifies Q7 guidance on API GMP manufacturing

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.

Health Canada asks importers to quarantine Polydrug APIs over data concerns

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.

Saneca buys Europe's only independent, US FDA approved Beta-lactams plant

25-Jun-2015 - API firm Saneca Pharmaceuticals has acquired struggling drug formulator Suir Pharma Ireland in a deal with former owner Mutares AG.

News in brief

Thermo Fisher will pay £256m for Alfa Aesar

25-Jun-2015 - Thermo Fisher Scientific has anncouned plans to buy research chemicals firm Alfa Aesar from Johnson Matthey for £256m ($405m).

UK scientists discover key poppy alkaloid production enzyme

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.

New nanotech excipient makes for better delayed-release drugs say researchers

22-Jun-2015 - Swedish scientists who developed the solubility enhancing nanotech excipient Upsalite say it can also be used to improve delayed release formulations.

ScinoPharm to make API for Chinese drugmaker eyeing US celecoxib market

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.

Slovenian regulators slam Polydrug API plant in India

17-Jun-2015 - Polydrug Laboratories chose not to log customer complaints about APIs made at its plants in Maharashtra according to Slovenian regulators.

API plant inspections to continue despite rule change say South African 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.

Nucleation knowhow can aid API makers say crystal experts due to meet in France

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.

Johnson Matthey: Ageing population and generics will drive API biz; Alfa Aesar sale on track

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. 

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