International Coalition of Medicines Regulatory Authorities

Dipharma Receives the 2nd GMP Certification from Brazilian ANVISA

Retrieved on: 
Thursday, October 26, 2023
ANVISA, Good, Good manufacturing practice, Caronno, US, International Coalition of Medicines Regulatory Authorities, Certification, CDMO, Active ingredient, Regulation, GMP, Cosmetics, Caronno Pertusella

MILAN, Italy, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Dipharma Francis S.r.l.

Key Points: 
  • MILAN, Italy, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Dipharma Francis S.r.l.
  • This authorization joins the previous one, obtained in November 2022, by the Dipharma Italian site located in Baranzate (Milan), and certifies Dipharma world-class quality system, which has been widely recognized by regulatory authorities.
  • “We are very proud to have reached another regulatory milestone: this second successful completion of the ANVISA certification recognizes another Dipharma site as being in compliance with the GMP requisites as foreseen by the Brazilian requirements,” said Jorge Nogueira, Chief Executive Officer of Dipharma Francis S.r.l.
  • — “Our Company is committed to providing innovative and competitive solutions to our customers and this achievement once again certifies we are an ideal partner for registering new applications at ANVISA.”

Dipharma receives GMP certification from Brazilian ANVISA

Retrieved on: 
Thursday, December 1, 2022
Active ingredient, Certification, Good manufacturing practice, International Coalition of Medicines Regulatory Authorities, API, ANVISA, CDMO, CBPF, CGMP, Regulation, Regulatory Agencies, US, Plant, GMP, Yahoo Beijing Global R&D Center, Good, Intermediate 1, Fine chemical, U.S.A, Baranzate

It is the first Dipharma manufacturing facility to receive ANVISA certification.

Key Points: 
  • It is the first Dipharma manufacturing facility to receive ANVISA certification.
  • This authorization certifies the strict adherence of Dipharmas quality system to GMP requirements and allows Dipharma to be the right choice for all customers who would like to register new applications at ANVISA.
  • We are very pleased to have obtained this first successful completion of the ANVISA certification said Jorge Nogueira, Chief Executive Officer of Dipharma Francis S.r.l.
  • As a third-generation family-owned company, Dipharma has a long history of stability, commitment, and financial solidity.

PhaseBio Announces European Licensing Agreement with Alfasigma S.p.A for Commercialization of Bentracimab

Retrieved on: 
Thursday, June 17, 2021
Medical Supplies, Health, Hospitals, General Health, Pharmaceutical, Biotechnology, Government, Canary Wharf, Department of Health and Social Care, Medicines and Healthcare products Regulatory Agency, Organizations, European Medicines Agency, Health care, MHRA, International Coalition of Medicines Regulatory Authorities, Regulation of therapeutic goods, Bentracimab (PB2452), PhaseBio, Alfasigma, BENTRACIMAB (PB2452), PHASEBIO, ALFASIGMA

The agreement covers countries in the European Union and European Economic Area, as well as the United Kingdom, Russia, Ukraine and other countries within the Commonwealth of Independent States.

Key Points: 
  • The agreement covers countries in the European Union and European Economic Area, as well as the United Kingdom, Russia, Ukraine and other countries within the Commonwealth of Independent States.
  • PhaseBio will be responsible for developing bentracimab and securing approval with the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), after which marketing authorization will be assigned to Alfasigma.
  • The signing of this commercialization agreement with our new partner, Alfasigma, is a truly momentous occasion for PhaseBio, said Jonathan P. Mow, Chief Executive Officer of PhaseBio Pharmaceuticals.
  • We share a high degree of enthusiasm with PhaseBio as we look forward to building the global bentracimab brand across Europe and other key markets.