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28.11.2022

Overcoming process development challenges following a changing peptide regulatory landscape

Pavel Parkhomyuk
Pavel Parkhomyuk

Complex API Science, Technology and CMC Manager

  • Regulatory Affairs
  • R&D
Overcoming process development challenges following a changing peptide regulatory landscape
Pavel Parkhomyuk
Pavel Parkhomyuk

Complex API Science, Technology and CMC Manager
  • Article
  • Regulatory Affairs
Pavel Parkhomyuk
24.08.2022

Complex Generics Made Simple — Fermentation

  • R&D
Complex Generics Made Simple — Fermentation

  • Article
  • R&D
10.08.2022

Complex Generics Made Simple — the Respiratory Segment

  • R&D
  • Whitepaper
Complex Generics Made Simple — the Respiratory Segment

  • Article
  • R&D
01.08.2022

Effective Procedures for Bulk Product Sampling

  • R&D
Effective Procedures for Bulk Product Sampling

  • Article
  • R&D
18.07.2022

What does it take to be an expert in fermentation?

  • R&D
  • Products
What does it take to be an expert in fermentation?

  • Article
  • R&D
13.07.2022

What is High Potency Expertise?

  • R&D
  • Products
What is High Potency Expertise?

  • Article
  • R&D
19.06.2022

Podcast: ESG in Pharma – Why it Makes a Difference

  • ESG
  • Podcast
Podcast: ESG in Pharma – Why it Makes a Difference

  • Article
  • ESG
10.05.2022

The New CADIFA Regulations in Brazil, Explained

  • Regulatory Affairs
  • LATAM 
The New CADIFA Regulations in Brazil, Explained

  • Article
  • Regulatory Affairs

As novas regulamentações sobre CADIFA no Brazil, explicadas

  • Regulatory Affairs
  • LATAM 
As novas regulamentações sobre CADIFA no Brazil, explicadas

  • Article
  • Regulatory Affairs
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Last site inspections

  • Nov 16, 2021 Teva API had a successful inspection in the Teva api India Gajraula site by UP State FDA
  • Jul 20, 2021 Teva API had a successful inspection in the Teva api Czech site by SUKL
  • Jun 22-23, 2021 Teva API had a successful inspection in the Teva api India Malanpur site by Local MOH
View all Site Inspections

Last regulatory updates

  • Nov 14, 2022 EU DMF
  • Aug 28, 2022 CADIFA
  • Feb 08, 2022 US DMF
View all Regulatory Updates

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