APIs (active pharmaceutical ingredients)

G1 Therapeutics: trilaciclib shows benefits for lung cancer patients

14-May-2020 By Jenni Spinner

The company will present data from recent Phase 2 trials of the investigational drug at the upcoming ASCO20 virtual conference on May 29.

Gilead, Cipla partner on remdesivir expansion

14-May-2020 By Jenni Spinner

The two companies will join forces on wider manufacturing and distribution of the investigational drug, granted an EUA to treat COVID-19 patients.

Nanoform granted GMP certification

14-May-2020 By Jenni Spinner

The Finnish nanoparticle technology specialist’s facility has been given the stamp of approval by the Finnish Medicines Agency.

Quartic.ai, Bright Path Labs to partner on AI-powered API manufacturing

11-May-2020 By Jenni Spinner

The two firms are joining forces to develop AI-based technology for continuous manufacturing of critical APIs necessary for producing crucial small-molecule drugs.

FDA requests recall of ranitidine drug products

02-Apr-2020 By Jenni Spinner

The agency is asking manufacturers to withdraw all products containing ranitidine due to contamination concerns around a possible carcinogen.

FDA updates and actions on COVID-19

01-Apr-2020 By Jenni Spinner

The federal agency has announced a slew of legislation, advisory statements and other items impacting the US in the face of the pandemic.

FDA grants chloroquine emergency authorization as coronavirus treatment

30-Mar-2020 By Vassia Barba

The US FDA has issued the first emergency use authorization to chloroquine phosphate and hydroxychloroquine sulfate as treatments against coronavirus.

India invests to boost domestic API manufacture

26-Mar-2020 By Ben Hargreaves

Following API constraints due to the coronavirus, the Indian government takes measures to bolster domestic capabilities.

FDA lifts import alert on Ipca Labs for chloroquine supply

24-Mar-2020 By Ben Hargreaves

In order to boost the supply of chloroquine, the US FDA has allowed Ipca to supply APIs and finished product to the country.

Industry ups chloroquine production, donates millions of doses

23-Mar-2020 By Ben Hargreaves

Manufacturers of hydroxychloroquine are increasing production and a number have offered to donate doses to combat COVID-19.

Sanofi currently ‘does not anticipate’ medicine shortages

17-Mar-2020 By Ben Hargreaves

With the coronavirus impacting the supply of API, Sanofi issues a notice that its global network is secure.

US FDA details problems that led to Biocon’s Form 483

13-Mar-2020 By Ben Hargreaves

The published Form 483 details five points of concern raised by inspectors to the company’s API facility in India.

EMA says shortages due to coronavirus ‘cannot be excluded’

11-Mar-2020 By Vassia Barba

Evaluating the situation, the EMA has formed an Executive Steering Group to address the impact of the coronavirus outbreak on the supply of medicines.

Formulation method improves bioavailability of poorly soluble molecules

09-Mar-2020 By Vassia Barba

Orion to benefit from Nanoform’s formulation technology, which is able to improve bioavailability and solubility of early-stage compounds.

Indian export group says European industry ‘panicking’ over APIs

05-Mar-2020 By Ben Hargreaves

After the Indian government moved to limit the export of APIs, an Indian export association says fear is spreading amongst European businesses over supply.

Indian government shuts down export of certain APIs due to coronavirus

03-Mar-2020 By Ben Hargreaves

With the supply of certain APIs limited by the spread of the virus, Indian government orders restrictions on the export of ingredients and formulations.

Mylan foresees potential coronavirus impact on finances

02-Mar-2020 By Vassia Barba

Mylan CEO sees potential hit in the company’s finances due to the coronavirus outbreak as the organization prepares for the launch of Viatris.

FDA reports first drug shortage due to coronavirus outbreak

02-Mar-2020 By Vassia Barba

The US FDA announces shortage of a drug due to a site affected by coronavirus, as it focuses on the protection of the supply chain from outbreak impacts.

Sanofi to spin-out and launch European API manufacturer

25-Feb-2020 By Ben Hargreaves

According to the French company, the spinout would enter the market as the second largest API producer globally.

‘You get what you pay for’ on API quality

19-Feb-2020 By Ben Hargreaves

As C2 Pharma works to expand its API portfolio, its CEO states that there is ‘no short game’ on API quality.

Lupin denies quality is a company-wide issue despite run ins with FDA

18-Feb-2020 By Nick Taylor

Lupin refutes suggestion that history of manufacturing quality failings highlighted by the US FDA reflect a company-wide issue.

Tetra in manufacturing deal for printed CBD treatment

18-Feb-2020 By Ben Hargreaves

Tetra Bio-Pharma signs agreement for the commercial manufacture of two CBD-based drug candidates.

Sun Pharma blames 'speculative buying' on coronavirus-related price hikes

17-Feb-2020 By Nick Taylor

Sun Pharma argues rising ingredient and finished product prices are unjustified, blames ‘speculative buying’ for trend.

Cardinal tips API supply chain to weather impact of coronavirus

10-Feb-2020 By Nick Taylor

Cardinal predicts API industry ‘should be able to work through’ coronavirus outbreak despite exposure to China.

Biocon hit with FDA 483 after inspection of API facility

06-Feb-2020 By Nick Taylor

US FDA issues Form 483 to Biocon facility after preapproval and GMP inspections.

Pfizer's CDMO unit drives growth at hospital business

03-Feb-2020 By Nick Taylor

Pfizer attributes performance of contract manufacturing unit as driver of growth at hospital business.

Could the coronavirus impact supply of APIs?

29-Jan-2020 By Ben Hargreaves

First quarter supplies of APIs are expected to be affected by the recent outbreak of coronavirus, according to survey.

UPDATED

Civica Rx signs 7-year deal with Thermo Fisher

20-Jan-2020 By Ben Hargreaves & Nick Taylor

The non-profit agrees deal with Thermo Fisher to develop and manufacture essential medications at risk of shortages.

PharmaMar to supply Jazz with drug product under $1bn deal

16-Jan-2020 By Nick Taylor

PharmaMar set to supply Jazz Pharmaceuticals with cancer drug from two sites under terms of $1bn deal.

Sterling expects further HPAPI demand, looks for buy-out opportunities

15-Jan-2020 By Vassia Barba

Sterling continues expansion and lines up further acquisitions, as the HPAPI market continues to see increasing demand, a company executive says.

Alcami sells Dutch API facility to MercachemSyncom

14-Jan-2020 By Ben Hargreaves

Alcami downsizes in Europe through the sale of its API facility to MercachemSyncom, as it expands its presence in North America.

Lab urges FDA to suspend ranitidine sales due to degradation risk

13-Jan-2020 By Nick Taylor

Emery Pharma files citizen petition arguing data on the degradation of ranitidine supports suspension of the medicine.

Mylan recalls close-to-expiration nizatidine capsules over NDMA impurity

09-Jan-2020 By Ben Hargreaves

The recall of products due to NDMA contamination continues, with a new medication, nizatidine, now thought to be affected by the probable carcinogen.

Agilent sets sights on filling new nucleic acid plant by 2021

16-Dec-2019 By Nick Taylor

Agilent looks to fill new nucleic acid capacity by end of 2020, eyes further expansions.

NDMA investigation leads to cases discovered in diabetes treatment

09-Dec-2019 By Ben Hargreaves

After NDMA contamination is found by Singaporean authorities, both the FDA and EMA state they are working on the testing of metformin treatments.

Almac granted $1m to develop low-cost API manufacturing method

09-Dec-2019 By Vassia Barba

Under funding from Bill and Melinda Gates Foundation, Almac initiates work to develop biosynthetic routes for APIs to be used in world aid programs.

Horizon opens West Coast manufacturing site to tap talent pool

03-Dec-2019 By Nick Taylor

Horizon Therapeutics opens South San Francisco, US, manufacturing and R&D site to tap into talent pool in biotech hotspot.

FDA approves first drug to target the root cause of sickle cell disease

02-Dec-2019 By Vassia Barba

Global Blood Therapeutics receives approval for Oxbryta, making it the first approved drug product that targets the root cause of sickle cell disease.

Recipharm strikes £505M takeover of Consort

25-Nov-2019 By Nick Taylor

Recipharm strikes £505m takeover of Consort Medical to leapfrog into top tier of CDMOs.

Heraeus adds ‘much-needed’ capacity for chemo components manufacture

25-Nov-2019 By Vassia Barba

Heraeus adds production line to expand its capacity for the manufacture of platinum-based HPAPIs.

US FDA nod for Shionogi’s antibiotic targeting resistant bacteria

18-Nov-2019 By Vassia Barba

US FDA approves Fetroja, an antibiotic developed by Shionogi, for the treatment of complicated urinary tract infections, as part of the effort to fight AMR.

FDA hits Zydus Cadila plant with another warning letter

11-Nov-2019 By Nick Taylor

US FDA serves Zydus Cadila’s sterile injectables plant with a warning letter for the second time in four years.

CPhI Worldwide 2019

Exothermic reactions at -60°C for continuous API manufacture

11-Nov-2019 By Vassia Barba

Driven by market demand, De Dietrich develops an API production set that enables continuous manufacturing of molecules that require exothermic chemical reactions.

FDA's Woodcock details national security risks of global supply chains

07-Nov-2019 By Nick Taylor

FDA’s Janet Woodcock testifies to Congress about the potential risks to US national security of the pharmaceutical industry’s reliance on Chinese imports.

The scale of generic uptake in the major markets

01-Nov-2019 By Ben Hargreaves

The divergence across global market penetration of generic medicines is broad, with some countries’ markets worth close to half of the entire sector or as low as one fifth, according to IGBA.

Bryn declares patient preference for nasal spray over EpiPen

29-Oct-2019 By Ben Hargreaves

Bryn Pharma presents data from a patient study that showed a consistent choice of its nasal spray formulation of epinephrine over Mylan’s EpiPen.

Novartis to outsource API supply and cut 320 jobs in Ireland

28-Oct-2019 By Ben Hargreaves

As part of an evaluation of its manufacturing network, the company concluded that the Ringaskiddy production building was no longer a competitive, long-term option.

Sanofi and Dr Reddy’s join the ranitidine recall

24-Oct-2019 By Ben Hargreaves

Both companies issue a voluntary recall of their ranitidine-based products due to the ongoing investigation into cancer-causing contamination.

Foamix enters commercial supply agreement for topical foam antibiotic

24-Oct-2019 By Staff Reporter

Foamix signs deal with ASM for the commercial manufacture and supply of recently approved Amzeeq and its lead candidate, FMX103.

Novo Nordisk’s $40m wastewater plant to be ‘economic driver’ for US state

21-Oct-2019 By Ben Hargreaves

Novo Nordisk completes the construction of a wastewater treatment plant in Clayton, North Carolina, which will be donated to the city to aid biopharma growth.