Suppliers / Melody Healthcare

Melody Healthcare

India 1 employees Updated 9 July 2026

Melody Healthcare is an API and finished-dose manufacturer based in India. It holds 12 active US drug master files and 13 valid CEPs across a filed portfolio of 15 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 12 December 2025 as VAI. Customs aggregates show $10.0M of exports covering 420 molecules to 43 destinations in 2025.

12
active US DMFs
13
valid CEPs
5
registered plants 1 with an FDA FEI number
3
filings across 1 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

  • 12 December 2025 VAI US FDA
  • 24 August 2018 NAI US FDA

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

Registered plants

Site FDA FEI
Mumbai, India Not on file
Mumbai, India Not on file
Boisar, India Not on file
Boisar, India Not on file
Palghar, India 3009118300

What they file, and where

Molecule Regulators Docs
Albuterol EDQM, SFDA (Saudi Arabia), US FDA 5
Tigecycline EDQM, SFDA (Saudi Arabia), US FDA 5
Salmeterol EDQM, SFDA (Saudi Arabia), US FDA 4
Rosuvastatin EDQM, US FDA 3
Terbutaline EDQM, SFDA (Saudi Arabia), US FDA 3
Formoterol EDQM, US FDA 2
Montelukast EDQM, US FDA 2
Glycopyrronium US FDA 1
Glycopyrronium Bromide EDQM 1
Indacaterol US FDA 1
Show all 15 molecules on file
Ipratropium EDQM 1
Levosimendan US FDA 1
Ramipril EDQM 1
Umeclidinium Bromide US FDA 1
Vilanterol US FDA 1

Also appears on these molecule pages

Albuterol API Formoterol API Glycopyrronium API Indacaterol API Ipratropium API Levosalbutamol finished dose Montelukast API Ramipril API Rosuvastatin API Salbutamol API Salmeterol API Terbutaline API
Show 3 more molecule pages
Tigecycline API Umeclidinium API Vilanterol API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 3 None
EMA None 1
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $2.4M 21
2025 Not reported $10.0M 43
2024 Not reported $11.0M 42
2023 Not reported $9.0M 36

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 We do not publish the identity of any buyer.

Questions about Melody Healthcare

Does Melody Healthcare hold a US DMF or a CEP?
Melody Healthcare holds 12 active US drug master files and 13 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 Melody Healthcare FDA-registered?
One site operated by Melody Healthcare 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 Melody Healthcare's last inspection go?
The most recent inspection on record closed on 12 December 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Melody Healthcare manufacture?
5 registered sites are on record, in India (Mumbai, Boisar and Palghar among others). Every site is listed on this page with the register it came from.
What does Melody Healthcare make?
15 molecules are on record against Melody Healthcare, including Albuterol, Tigecycline, Salmeterol and Rosuvastatin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Melody Healthcare's GMP?
Current GMP certificates are on record from EMA and US FDA. 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 12 December 2025.

Comparable suppliers

Cipla shares 10 molecules Neuland Laboratories shares 7 molecules Olon shares 6 molecules Lupin shares 6 molecules Vamsi Labs shares 6 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
Customs aggregates
Export values, molecule and destination counts