Site records / Gujarat / FEI 3007277149

Intas Pharmaceuticals LimitedAhmedabad, Gujarat

FDA-registered drug establishment in Ahmedabad, Gujarat: analysis, api manufacture, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
None
Last inspection
None posted
Warning letters to this FEI
0
Import alerts at this address
0 of 2 under the name
US border refusals, 2 years
2
The site dossier

The full record.
Every fact sourced.

  • A grade from A to E on a registered ten-factor rubric, with the fact behind every factor
  • Every posted FDA citation, sorted into failure categories and set against Indian drug inspections
  • Warning-letter violations, numbered and labelled
  • Import-alert history rebuilt from the archive, each listing checked against this address
  • Border refusals by product, and the company's other sites, each graded
  • A hash of every source read, so the PDF can be checked against the record

On 2022–26 inspections the rubric never saw, grade E sites were classified OAI 26.5% of the time and grade A sites 4.0%.

FDA has posted no classified inspection for this site, so its dossier carries no grade. It holds the rest of the record: registration, import alerts, border refusals and the company's other sites.

PDF and data by email, usually within minutes, as of the day you buy. Card payment through Razorpay.

By buying you agree to the Terms and the refund policy: sales are final once delivered, except non-delivery.

Consultant plan · US$799 a month · five dossiers a month and watchlist alerts. Ask about the plan

Inspections

FDA has posted no inspection of this FEI. That is an absence of record, not a clean one.

Warning letters and compliance actions

  1. 30 Mar 2026Warning letter to Intas Pharmaceuticals Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
  2. 21 Nov 2023Warning letter to Intas Pharmaceuticals Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
  3. 28 Jul 2023Warning letter to Intas Pharmaceuticals Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI

Import alerts in force

Import-alert pages list a firm name and an address, never an FEI. Each listing under this firm's name is shown with the address FDA published and whether it is this site's.

  1. 14 Nov 2023Import alert 66-40 · Published address is another site of this firm SourcePublished address: Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi , Sarkhej-Bavla Highway, Taluka-Sanand, Matoda , Ahmedabad, Gujarat INDIA
  2. 1 Jun 2023Import alert 66-40 · Published address is another site of this firm SourcePublished address: Pharmez Plot No 5-14 , Near Village Matoda; Sarkhej-Bavla Highway No 8-A , Sanand, Gujarat INDIA

Registration

FEI
3007277149
DUNS
677378034
Registered as
Intas Pharmaceuticals Limited
Registrant
Intas Pharmaceuticals Limited
Address
Plot No 423/P/A, Sarkhej-Bavla Highway, Moraiya, Ahmedabad, Gujarat 382213, India (IND)
Operations
ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK
Registration expires
31 Dec 2026

Sources: FDA drug establishment registrations, FDA Data Dashboard inspections and compliance actions, import-alert pages, warning letters, import refusals and the FDA reading room, as held in Counterfoil's point-in-time corpus. No matched action does not establish compliance, and FDA registration is not FDA approval. Sources and coverage.

COUNTERFOIL / CONTACT

Contact us.

How can we help?

Stored privately by Counterfoil. Your email is used only to respond to your enquiry.