Regulatory Affairs

Regulatory affairs specialists work at the interface between business and government regulations, shepherding medical products from inception to market.
Regulatory Affairs team at Alembic is a compact unit covering filings in voluminous global markets ranging from Regulated markets like US and Europe to several Semi-Regulated markets.

We have remarkable number of ANDAs filed and approved for US market, followed by many filings in Europe, Canada, Australia, South Africa, Brazil, LATAM, ASEAN and ROW markets.

The active substance filings (DMF/COS) are extended to US, Europe, Australia, Canada with number of COS approvals.

We constantly upgrade Our regulatory intelligence to comply with the dynamic regulatory requirements, making us strategically poised for regulated markets. Our constant strive towards globalization has been endorsed by a huge number of approvals from across the global markets.

Drug Product Filings:

  • US
  • Europe
  • Australia
  • ROW(covering ASEAN, SA, WB, African countries)
  • LATAM (covering Brazil)
  • 73 ANDAs, including 01 NDA with 43 approvals
  • 100 with 76 approvals
  • 16 with 13 approvals
  • 62
  • 20

Active Substance Filings:

  • TPD, Canada
  • CEP
  • 83
  • 37
  • filled with 33 approvals