Suppliers / Hy-Gro Chemicals Pharmtek

Hy-Gro Chemicals Pharmtek

India Updated 9 July 2026

Hy-Gro Chemicals Pharmtek is an API manufacturer based in India. It holds 4 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 22 May 2025 as VAI. Customs aggregates show $21.6M of exports covering 259 molecules to 30 destinations in 2025.

4
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 22 May 2025 VAI US FDA
  • 22 November 2019 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Medak, India 3009609117
Hyderabad, India Not on file

What they file, and where

Molecule Regulators Docs
Dextromethorphan US FDA 2
Doxylamine US FDA 2
Flurbiprofen SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $2.6M 16
2025 Not reported $21.6M 30
2024 Not reported $22.7M 30
2023 Not reported $25.6M 34

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Hy-Gro Chemicals Pharmtek

Does Hy-Gro Chemicals Pharmtek hold a US DMF or a CEP?
Hy-Gro Chemicals Pharmtek holds 4 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Hy-Gro Chemicals Pharmtek FDA-registered?
One site operated by Hy-Gro Chemicals Pharmtek carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Hy-Gro Chemicals Pharmtek's last inspection go?
The most recent inspection on record closed on 22 May 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Hy-Gro Chemicals Pharmtek manufacture?
2 registered sites are on record, in India (Medak and Hyderabad). Every site is listed on this page with the register it came from.
What does Hy-Gro Chemicals Pharmtek make?
3 molecules are on record against Hy-Gro Chemicals Pharmtek, including Dextromethorphan, Doxylamine and Flurbiprofen. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hy-Gro Chemicals Pharmtek's GMP?
Current GMP certificates are on record from US FDA and EMA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 22 May 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts