Suppliers / Bal Pharma

Bal Pharma

India reconciled across 9 public records · 5 entities Updated 9 July 2026

Bal Pharma is an API and finished-dose manufacturer based in India. It holds 2 active US drug master files and 7 valid CEPs across a filed portfolio of 7 molecules. Its filings concentrate with TMDA (TZ), NAFDAC (NG) and MCAZ (ZW). Its GMP standing is certified by EMA, CDSCO (India) and NAFDAC (NG), among 4 authorities. Customs aggregates show $22.4M of exports covering 1,090 molecules to 77 destinations in 2025.

2
active US DMFs
7
valid CEPs
7
registered plants
60
filings across 11 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Bangalore, United Arab Emirates Not on file
Bangalore, India Not on file
Bengaluru, India Not on file
Rudrapur, India Not on file
Bengaluru, India Not on file
bengaluru 560099, India Not on file

1 further sites are on record.

What they file, and where

Molecule Regulators Docs
Gliclazide EDQM, SFDA (Saudi Arabia) 8
Adapalene EDQM, SFDA (Saudi Arabia) 3
Benzydamine EDQM, SFDA (Saudi Arabia) 3
Amiloride EDQM 2
Bepotastine US FDA 2
Deferasirox EDQM 2
Ebastine EDQM 2

Also appears on these molecule pages

Adapalene API Deferasirox API Ebastine API Gliclazide API Ketoconazole finished dose Silver Sulfadiazine finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
TMDA (TZ) 18 None
NAFDAC (NG) 16 3
MCAZ (ZW) 9 1
MINSA (CR) 9 None
ZAMRA (ZM) 7 None
EFDA (ET) 3 None
EMA None 6
CDSCO (India) None 3

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.9M 26
2025 Not reported $22.4M 77
2024 Not reported $21.5M 79
2023 Not reported $25.6M 82

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 We do not publish the identity of any buyer.

Questions about Bal Pharma

Does Bal Pharma hold a US DMF or a CEP?
Bal Pharma holds 2 active US drug master files and 7 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.
Where does Bal Pharma manufacture?
7 registered sites are on record, in United Arab Emirates, India and Nigeria (Bangalore, Bengaluru and Rudrapur among others). Every site is listed on this page with the register it came from.
What does Bal Pharma make?
7 molecules are on record against Bal Pharma, including Gliclazide, Adapalene, Benzydamine and Amiloride. Each links through to that molecule's full manufacturer list.
Which regulators recognise Bal Pharma's GMP?
Current GMP certificates are on record from EMA, CDSCO (India), NAFDAC (NG) and MCAZ (ZW). 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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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