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APIs (active pharmaceutical ingredients)

News headlines

Biolabex's Mauritius R&D lab open for business

23-Feb-2017 - Biolabex has opened a manufacturing and R&D laboratory at BioPark Mauritius, a biohub in Vacoas-Phoenix south of the capital Port Louis.

Dr. Reddy's' Miryalaguda plant issued with Form483 after US FDA audit

23-Feb-2017 - Dr Reddy’s Laboratories has been issued with a Form483 after an inspection at its active pharmaceutical ingredient (API) plant in Miryalaguda in Telangana, India.

Modus raises cash for Ph II trial of Sickle Cell drug in EU, Middle East and Caribbean

22-Feb-2017 - Modus Therapeutics AB has raised an additional 32m SEK (£2.85m) for its Phase II trial for pain crises in Sickle Cell Disease, running in the Caribbean, Middle East and Europe.

AmpTec looking to achieve full GMP compliance for APIs

21-Feb-2017 - AmpTec GmbH is in the process of achieving full GMP compliance for API manufacturers in order to expand its offerings into the clinical space.

Cancer drug plant likely source of radio isotope detected across Europe say experts

21-Feb-2017 - A radiopharmaceuticals plant is the most likely source of the radioactive iodine-131 detected in several countries in recent weeks according to experts.

Granules to expand Indian API plants and US dosage form site

21-Feb-2017 - Granules India will build an API production facility in Bonthapally, Telangana and expand other manufacturing sites in a project backed by the Word Bank. 

CMOs need to increase awareness of offerings, ISR reports

20-Feb-2017 - A "new set of leaders" emerged in the contract manufacturing organization (CMO) industry over the past year, though many remain unheard of, according to a recent report .

Tilray begins shipping medical marijuana to more countries

20-Feb-2017 - Medical marijuana developer Tilray has begun shipping to overseas patients and trial sites outside Canada after partnering with local distributors to comply with regional regulations.

Tilray grows capacity in North America's only GMP cannabis facility

16-Feb-2017 - Medical cannabis supplier Tilray has expanded its formulary team and mooted the idea of extending its distribution network just weeks after the EMA granted its Canadian production site GMP accreditation.

Is the return of the one-stop-shop model just a CMO marketing ploy?

16-Feb-2017 - End-to end service offerings are a differentiator within the fragmented CMO industry and not driven by pharma demand, a Results Healthcare report says.

Dr. Reddy's Laboratories continues European hospital market expansion

16-Feb-2017 - Dr. Reddy’s Laboratories Ltd has said it may invest in additional manufacturing capacity to support its efforts to grow in the European hospital drug market.

Teva sees higher active pharmaceutical ingredient sales in 2016

15-Feb-2017 - Copaxone maker Teva Pharmaceutical Industries Ltd. saw higher active pharmaceutical ingredient (API) sales last year.

News in brief

Sun Pharmaceutical Industries sees API sales slide in Q3

15-Feb-2017 - Sun Pharmaceutical Industries Ltd. saw lower active pharmaceutical ingredient (API) revenue in the third quarter of fiscal 2017.

Stada confirms €3.5bn bid from Cinven and interest from Advent

14-Feb-2017 - API manufacturer Stada Arzeneimittel AG has received an acquisition offer from private equity firm Cinven Ltd., and an expression of interest from Advent International Corp.

Indian API maker slammed by US FDA for water and cleaning issues

14-Feb-2017 - The US FDA has issued a warning letter to Indian API maker Resonance Laboratories Private Limited citing inadequate cleaning procedures at its facility in Bangalore.

India asks drug firms to help discourage off-prescription antibiotic sales

13-Feb-2017 - Indian regulators want manufacturers to discourage pharmacists from selling antibiotics to patients without prescriptions as part of an effort to curb the spread of superbugs.

Pfizer to shut Australian Neulasta biosimilar plant and move production to Croatia

10-Feb-2017 - Pfizer will close the Australian plant which produces the API for HSP-130, a candidate version of Amgen’s Neulasta, and shift production to Croatia.

India to allow API firms to request EU quality confirmations online

09-Feb-2017 - Indian regulators will allow API firms to seek the confirmations needed to ship to the EU online from next month.

Workers strike at Merck injectable drug plant in Goa, India over wages

09-Feb-2017 - Workers at a Merck KGaA injectable drug and soft gel capsules plant in Goa, India have gone on strike over a wages dispute.

Pot luck? Medical marijuana's 'questionable quality’ no threat to pharma R&D

08-Feb-2017 - Pharma firms using cannabis-derived ingredients have hit out at the lack of standardization and the questionable quality of medical marijuana.

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