Suppliers / Precise Biopharma

Precise Biopharma

India 112 employees Updated 9 July 2026

Precise Biopharma is an API and finished-dose manufacturer based in India. It holds one valid CEP. Its GMP standing is certified by EMA. Customs aggregates show $8.5M of exports covering 441 molecules to 51 destinations in 2025.

0
active US DMFs
1
valid CEPs
2
registered plants
20
filings across 1 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
Mumbai, India Not on file
Navi Mumbai, India Not on file

What they file, and where

Molecule Regulators Docs
Naphazoline EDQM 1

Also appears on these molecule pages

Bempedoic Acid finished dose Naphazoline API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 20 None
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.1M 27
2025 Not reported $8.5M 51
2024 Not reported $6.9M 43
2023 Not reported $4.2M 42

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 We do not publish the identity of any buyer.

Questions about Precise Biopharma

Does Precise Biopharma hold a US DMF or a CEP?
Precise Biopharma holds 1 valid CEP. 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 Precise Biopharma manufacture?
2 registered sites are on record, in India (Mumbai and Navi Mumbai). Every site is listed on this page with the register it came from.
What does Precise Biopharma make?
1 molecule is on record against Precise Biopharma, including Naphazoline. Each links through to that molecule's full manufacturer list.
Which regulators recognise Precise Biopharma's GMP?
Current GMP certificates are on record from 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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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