Suppliers / Porton Pharma Solutions

Porton Pharma Solutions

China 300363.SZ 381 employees reconciled across 10 public records · 4 entities Updated 9 July 2026

Porton Pharma Solutions is an API manufacturer based in China. It holds 25 active US drug master files and 2 valid CEPs across a filed portfolio of 19 molecules. Its filings concentrate with EMA, DMP (NO) and URPL (PL). Its GMP standing is certified by MHRA (UK), US FDA and WHO (PQ), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 29 March 2024 as NAI.

25
active US DMFs
2
valid CEPs
6
registered plants 1 with an FDA FEI number
15
filings across 9 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 29 March 2024 NAI US FDA
  • 23 November 2018 VAI US FDA
  • 11 September 2015 VAI US FDA

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

Registered plants

Site FDA FEI
Chongqing, China Not on file
Changshou, China Not on file
Chongqing, China Not on file
Changshou, China Not on file
China, China 3006625990
SALISBURY, United Kingdom Not on file

What they file, and where

Molecule Regulators Docs
Nicotine EDQM, US FDA 3
Abemaciclib US FDA 1
Alectinib US FDA 1
Baloxavir Marboxil US FDA 1
Dapagliflozin US FDA 1
Darunavir US FDA 1
Dexrazoxane US FDA 1
Hydroxychloroquine EDQM 1
Isavuconazonium US FDA 1
Mefloquine US FDA 1
Show all 19 molecules on file
Niraparib US FDA 1
Phloroglucinol US FDA 1
Relugolix US FDA 1
Rimegepant US FDA 1
Salmeterol US FDA 1
Tiopronin US FDA 1
Venetoclax US FDA 1
Vibegron US FDA 1
Vonoprazan US FDA 1

Also appears on these molecule pages

Abemaciclib API Alectinib API Baloxavir Marboxil API Darunavir API Dexrazoxane API Hydroxychloroquine API Isavuconazonium API Nicotine API Niraparib API Phloroglucinol API Relugolix API Rimegepant API
Show 5 more molecule pages
Salmeterol API Venetoclax API Vibegron API Vonoprazan API Dapagliflozin API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 6 1
DMP (NO) 2 None
URPL (PL) 1 None
ANSM (FR) 1 None
MPA (SE) 1 None
FAMHP (BE) 1 None
MHRA (UK) None 4
US FDA None 1
WHO (PQ) None 1

Questions about Porton Pharma Solutions

Does Porton Pharma Solutions hold a US DMF or a CEP?
Porton Pharma Solutions holds 25 active US drug master files and 2 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 Porton Pharma Solutions FDA-registered?
One site operated by Porton Pharma Solutions 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 Porton Pharma Solutions's last inspection go?
The most recent inspection on record closed on 29 March 2024 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file.
Where does Porton Pharma Solutions manufacture?
6 registered sites are on record, in China and United Kingdom (Chongqing, Changshou and China among others). Every site is listed on this page with the register it came from.
What does Porton Pharma Solutions make?
19 molecules are on record against Porton Pharma Solutions, including Nicotine, Abemaciclib, Alectinib and Baloxavir Marboxil. Each links through to that molecule's full manufacturer list.
Which regulators recognise Porton Pharma Solutions's GMP?
Current GMP certificates are on record from MHRA (UK), US FDA, WHO (PQ) 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 NAI, on 29 March 2024.

Comparable suppliers

MSN Laboratories shares 8 molecules Dr Reddy's Laboratories shares 7 molecules Changzhou Pharmaceutical Factory shares 7 molecules Cipla shares 6 molecules Hetero shares 5 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