Sintetica

Switzerland Updated 9 July 2026

Sintetica is a finished-dose manufacturer based in Switzerland. It appears in 238 regulatory filings across 13 regulators, without an active US DMF or CEP on file. Its filings concentrate with SWISSMEDIC (CH), EMA and MPA (SE). Its GMP standing is certified by ZLG (DE), EMA and US FDA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 16 May 2023 as NAI.

active US DMFs

valid CEPs

registered plants 1 with an FDA FEI number

238

filings across 13 regulators

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

Plants

1 of 1 confirmed

Inspections

5 of 5 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

16 May 2023 NAI US FDA
20 September 2017 NAI US FDA
11 November 2014 NAI US FDA
30 October 2012 VAI US FDA
15 October 2010 VAI US FDA

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

Registered plants

Site	FDA FEI
Mendrisio, United Arab Emirates	Not on file
Switzerland, Switzerland	3008535840
Mendrisio, Switzerland	Not on file
Aschaffenburg, Germany	Not on file
North Rhine-Westphalia, Germany	Not on file
Muenster, Germany	Not on file

Filings and GMP by regulator

Regulator	Filings	GMP certificates
SWISSMEDIC (CH)	150	None
EMA	30	1
MPA (SE)	16	None
URPL (PL)	10	None
DMP (NO)	9	None
DKMA (DK)	7	None
ZLG (DE)	None	6
US FDA	None	1
ANVISA (Brazil)	None	1

Questions about Sintetica

Does Sintetica hold a US DMF or a CEP?

No active US drug master file or valid CEP is on record for Sintetica. It does have 238 filings with 13 regulators, so it is registered, just not with the two strong registers buyers usually screen on.

Is Sintetica FDA-registered?

One site operated by Sintetica 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 Sintetica's last inspection go?

The most recent inspection on record closed on 16 May 2023 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.

Where does Sintetica manufacture?

6 registered sites are on record, in United Arab Emirates, Switzerland and Germany (Mendrisio, Switzerland and Aschaffenburg among others). Every site is listed on this page with the register it came from.

Which regulators recognise Sintetica's GMP?

Current GMP certificates are on record from ZLG (DE), EMA, US FDA and ANVISA (Brazil). 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 NAI, on 16 May 2023.

Comparable suppliers

Acino Pharma also in Switzerland Alpex Pharma also in Switzerland Baccinex also in Switzerland Bracco Suisse also in Switzerland Drossapharm also in Switzerland

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