PharmaZell

Germany 376 employees reconciled across 12 public records · 3 entities Updated 9 July 2026

PharmaZell is an API manufacturer based in Germany. It holds 9 active US drug master files and 12 valid CEPs across a filed portfolio of 18 molecules. Its GMP standing is certified by EDQM, ZLG (DE) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 9 May 2025 as VAI.

active US DMFs

valid CEPs

registered plants 3 with an FDA FEI number

filings across 0 regulators

These figures were checked against the regulators' own files on 25 July 2026

Plants

1 of 1 confirmed

Inspections

4 of 4 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

9 May 2025 VAI US FDA
7 February 2025 VAI US FDA
30 June 2022 VAI US FDA
20 February 2020 VAI US FDA
14 December 2018 NAI US FDA
22 September 2017 VAI US FDA
11 August 2017 VAI US FDA
6 February 2015 VAI US FDA
12 December 2014 VAI US FDA
20 June 2014 VAI US FDA
8 December 2011 NAI US FDA
10 November 2011 NAI US FDA

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

Registered plants

Site	FDA FEI
Germany, Germany	3003725792
Raubling, Germany	Not on file
Chennai, India	3003602532
Chennai-600 045, India	Not on file
Visakhapatnam, India	Not on file
Anakapalli, India	3008248967

1 further sites are on record.

What they file, and where

Molecule	Regulators	Docs
Mesalazine	EDQM, PMDA (Japan), SFDA (Saudi Arabia), US FDA	4
Acetylcysteine	EDQM, US FDA	2
Celecoxib	EDQM, US FDA	2
Cholic Acid	EDQM, US FDA	2
Etoricoxib	SFDA (Saudi Arabia)	2
Propafenone	EDQM, US FDA	2
Teriflunomide	EDQM, US FDA	2
Ursodeoxycholic Acid	EDQM, US FDA	2
Ｌ‐カルボシステイン	PMDA (Japan)	2
Atenolol	PMDA (Japan)	1

Show all 18 molecules on file

Balsalazide	US FDA	1
Carbocisteine	EDQM	1
Cysteine	EDQM	1
Cystine	EDQM	1
Guanfacine	SFDA (Saudi Arabia)	1
Indapamide	EDQM	1
Methylene Blue	EDQM	1
「日局」Ｌ－カルボシステイン（製造専用）	PMDA (Japan)	1

Also appears on these molecule pages

Acetylcysteine API Carbocisteine API Cholic Acid API Etoricoxib API Guanfacine API Indapamide API Mesalamine API Mesalazine API Methylene Blue API Propafenone API Teriflunomide API Ursodeoxycholic Acid API

Show 1 more molecule pages

Celecoxib API

Filings and GMP by regulator

Regulator	Filings	GMP certificates
EDQM	None	12
ZLG (DE)	None	6
EMA	None	4
US FDA	None	2
CDSCO (India)	None	2

Questions about PharmaZell

Does PharmaZell hold a US DMF or a CEP?

PharmaZell holds 9 active US drug master files and 12 valid CEPs. 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 PharmaZell FDA-registered?

3 sites operated by PharmaZell carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.

How did PharmaZell's last inspection go?

The most recent inspection on record closed on 9 May 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 13 inspections are on file.

Where does PharmaZell manufacture?

7 registered sites are on record, in Germany and India (Germany, Raubling and Chennai among others). Every site is listed on this page with the register it came from.

What does PharmaZell make?

18 molecules are on record against PharmaZell, including Mesalazine, Acetylcysteine, Celecoxib and Cholic Acid. Each links through to that molecule's full manufacturer list.

Which regulators recognise PharmaZell's GMP?

Current GMP certificates are on record from EDQM, ZLG (DE), EMA, US FDA and CDSCO (India). 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 9 May 2025.

Comparable suppliers

Zydus Lifesciences shares 4 molecules Apitoria Pharma shares 3 molecules Ipca Laboratories shares 3 molecules Solara Active Pharma Sciences shares 3 molecules Optimus Drugs shares 3 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA: Drug master files, establishment registration, inspection classifications
EDQM: Certificates of suitability
EudraGMDP and national regulators: GMP certificates