Suppliers / Solara Active Pharma Sciences

Solara Active Pharma Sciences

India SOLARAPP1.BO Updated 9 July 2026

Solara Active Pharma Sciences is an API and finished-dose manufacturer based in India. It holds 91 active US drug master files and 32 valid CEPs. Its GMP standing is certified by CDSCO (India), US FDA and EMA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 6 February 2026 as VAI. Customs aggregates show $85.7M of exports covering 1,240 molecules to 62 destinations in 2025.

91
active US DMFs
32
valid CEPs
12
registered plants 6 with an FDA FEI number
2
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
6 of 6 confirmed
Inspections
8 of 8 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

  • 6 February 2026 VAI US FDA
  • 29 August 2025 VAI US FDA
  • 9 May 2025 NAI US FDA
  • 17 May 2024 NAI US FDA
  • 4 August 2023 NAI US FDA
  • 7 March 2020 OAI US FDA
  • 21 February 2020 NAI US FDA
  • 21 February 2020 NAI US FDA

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

Registered plants

Site FDA FEI
Anakapalli District, India 3016965485
Mysuru, India 3011856449
New Mangalore, India 3008252997
Chennai, India Not on file
cuddalore 607 005, India Not on file
Periyakalapet, India 3002808058

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Ibuprofen EDQM, SFDA (Saudi Arabia), US FDA 9
Mefenamic Acid EDQM, US FDA 4
Colchicine EDQM, SFDA (Saudi Arabia), US FDA 3
Dextromethorphan EDQM, US FDA 3
Hydralazine EDQM, SFDA (Saudi Arabia), US FDA 3
Levetiracetam EDQM, SFDA (Saudi Arabia), US FDA 3
Mycophenolic Acid EDQM, US FDA 3
Succinylcholine EDQM, SFDA (Saudi Arabia), US FDA 3
Aprepitant EDQM, US FDA 2
Bumetanide EDQM, US FDA 2
Show all 30 molecules on file
Buspirone EDQM, US FDA 2
Celecoxib EDQM, US FDA 2
Dipyridamole EDQM, US FDA 2
Disulfiram EDQM, US FDA 2
Etomidate EDQM, US FDA 2
Flecainide EDQM, US FDA 2
Gabapentin EDQM, US FDA 2
Mesalazine EDQM, US FDA 2
Mesna EDQM, US FDA 2
Mirabegron EDQM, US FDA 2
Mycophenolate Mofetil EDQM, SFDA (Saudi Arabia) 2
Naproxen US FDA 2
Nizatidine EDQM, US FDA 2
Olanzapine EDQM, US FDA 2
Oseltamivir EDQM, US FDA 2
Praziquantel EDQM, US FDA 2
Sevelamer US FDA 2
Venlafaxine EDQM, US FDA 2
Acitretin US FDA 1
Acyclovir US FDA 1

Also appears on these molecule pages

Show 63 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 2 5
US FDA None 5
EMA None 3
MFDS (Korea) None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $13.8M 40
2025 Not reported $85.7M 62
2024 Not reported $95.4M 63
2023 Not reported $95.8M 63

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

Questions about Solara Active Pharma Sciences

Does Solara Active Pharma Sciences hold a US DMF or a CEP?
Solara Active Pharma Sciences holds 91 active US drug master files and 32 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 Solara Active Pharma Sciences FDA-registered?
6 sites operated by Solara Active Pharma Sciences 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 Solara Active Pharma Sciences's last inspection go?
The most recent inspection on record closed on 6 February 2026 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 1 closed as OAI.
Where does Solara Active Pharma Sciences manufacture?
12 registered sites are on record, in India (Anakapalli District, Mysuru and New Mangalore among others). Every site is listed on this page with the register it came from.
What does Solara Active Pharma Sciences make?
30 molecules are on record against Solara Active Pharma Sciences, including Ibuprofen, Mefenamic Acid, Colchicine and Dextromethorphan. Each links through to that molecule's full manufacturer list.
Which regulators recognise Solara Active Pharma Sciences's GMP?
Current GMP certificates are on record from CDSCO (India), US FDA, EMA and MFDS (Korea). 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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 6 February 2026.

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