Tag: GMP Standards

Russia and Bulgaria signed cooperation agreement

Shestakov and Stoimenova
Last week in Sofia Vladislav Shestakov, Director of the State Institute of Drugs and Good Practices, Deputy Head of the State GMP Inspectorate met with Assena Stoimenova, Executive Director of the Bulgarian Drug Agency.

CellGenix expands its German facility

CellGenix, a global manufacturing leader of GMP-grade raw materials for cell therapy, gene therapy and tissue-engineered products, successfully completed the first phase of its headquarters’ expansion.

Russia amended procedure for state registration of some medicinal products

pharma manufacturing
The following amendments are introduced to the Russian Federal Law “On Circulation of Medicines" with regard to the state registration of medicinal products.

Samsung Biologics biggest plant received FDA approval

samsung biologics
Samsung BioLogics announced that a third monoclonal antibody Drug Substance has been licensed by the US FDA (Food and Drug Administration) for its second plant, the world’s largest single plant.

EMA withdraws the license from Taiwan’s pharma company

european medicines agency
The European Medicines Agency (EMA) is withdrawing the license of Taiwan-based Savior Liftec after the discovery of serious Good Manufacturing Practice (GMP) non-compliance after an inspection conducted earlier this month.

PIC/S approves new guidance on GMP inspections

pharmaceutical manufacturing
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced this month that it has adopted new guidance on good manufacturing practice (GMP) inspections.

The Russian Federation is preparing data integrity guidance for pharma industry

The State Institute for Drugs and Good Practices (SID&GP), a federal budget-funded institution, and PQE Group are working together on elaborating an industry data integrity guidance.

Pharma Research Products gains a generic botulinum toxin production company

Pharma Research Products Company Ltd. (PRP) a Korean company engaged in the development of medical esthetic products, secured majority ownership of botulinum toxin type A injection production facility of BioCND.

Romaco Innojet presents the first GMP compliant hot melt coating device

pills coating
Romaco Innojet has just come up with the first GMP compliant hot melt coating device specifically for use in the pharmaceutical industry. The IHD series was specially designed for coating and granulating pharmaceutical products.

CordenPharma boosts API manufacturing capacity

The expansion, which was completed in Q1 2018, will provide cGMP oligonucleotide manufacturing capacity up to 2mol, with a significant increase in total commercial capacity up to 500kg annually.

ProBioGen signed a second development agreement with Tizona Therapeutics

Under the terms of the agreement, ProBioGen is developing a stable cell line, followed by process development and GMP clinical manufacturing for Tizona’s lead antibody drug candidate.

EMA initiated a consultation focused on GMP non-compliance

european medicines agency
The European Medicines Agency (EMA) opened a public consultation period concerning the European Union’s template for Good Manufacturing Practice (GMP) noncompliance statements.

Chinese CDMO receives funding to expand GMP manufacturing capabilities

CMAB Biopharma, a Chinese full-service contract development and manufacturing organization (CDMO) providing process development and manufacturing services for biologic products, raised $34 million fin...

Idifarma announced new GMP spray drying capabilities

Idifarma, which specialises in niche and highly potent products, will be one of only three companies in the world offering this type of contract development and manufacturing spray drying service with...

Abzena upgraded its ADC GMP manufacturing facility

Abzena plc, the life sciences group, announced the completion of the facility remodelling for its new antibody-drug conjugate (ADC) GMP manufacturing suite at its Bristol, Pennsylvania

PPD expanded its GMP analytical laboratory

PPD Laboratories’ new GMP analytical laboratory supplements the company’s existing biologics capacity and was constructed specifically for the stability and quality control testing of large molecule drug products.