SERUM INSTITUTE OF INDIA PRIVATE LIMITED

Pune, IndiaFEI 3020223359API manufacture registered

SERUM INSTITUTE OF INDIA PRIVATE LIMITED is a drug establishment in Pune, India, registered with the US FDA under FEI 3020223359. Its registered operations are: Analytical testing, API manufacture, Labelling, Drug manufacture, Packaging. 7 EU/UK GMP certificates are matched to this site, 5 inspected within the last three years.

Sources: FDA Drug Establishments Current Registration Site (checked 2 Nov 2026); EudraGMDP; MHRA GMDP. Methodology

Registered operations

Business operations this establishment declares in its FDA registration. Registration is not an approval and says nothing about EU or UK GMP status.

Analytical testingAPI manufactureLabellingDrug manufacturePackaging

GMP documents matched to this site (7)

DocumentAuthorityInspectionSource
DK H 10001499
GMP certificate
Competent authority of Denmark7 Mar 2026
within 3-year review window
EudraGMDP
DK API-H 10001502
GMP certificate
Competent authority of Denmark7 Mar 2026
within 3-year review window
EudraGMDP
sukls8195/2025
GMP certificate
Competent authority of CZECHIA24 Jan 2025
within 3-year review window
EudraGMDP
DK H 10000977
GMP certificate
Competent authority of Denmark23 Jan 2024
within 3-year review window
EudraGMDP
DK API-H 10000978
GMP certificate
Competent authority of Denmark19 Jan 2024
within 3-year review window
EudraGMDP
UK GMP 13274 Insp GMP 13274/26823347-0001[H]
GMP certificate
MHRA4 Apr 2022
outside 3-year review window
MHRA-GMDP
UK GMP 13274 Insp GMP 13274/58149-0003[H]
GMP certificate
MHRA8 Feb 2021
outside 3-year review window
MHRA-GMDP

A GMP document is matched to this site when its address names the site's street and its city or postcode. In our latest internal review 59 of 60 sampled matches were the right site (not yet independently reviewed; measured match quality). Check the certificate's own address before relying on it. The three-year review window is the EMA guideline default after an inspection, not an official expiry date.

What this page does not show

  • Which substances are made here: DMFs and CEPs are filed by organisations, not sites, so we do not link substances to this site.
  • Capacity, scale, price or current availability: no regulator publishes these.
  • FDA inspection classifications for this site, which are not yet linked.