Suppliers / Shalina Laboratories

Shalina Laboratories

India 2 duplicate records merged Updated 9 July 2026

Shalina Laboratories is a finished-dose manufacturer based in India. It appears in 99 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with ZAMRA (ZM), NAFDAC (NG) and FDA (GH). Its GMP standing is certified by NAFDAC (NG) and FDA (GH). Customs aggregates show $61.8M of exports covering 8,322 molecules to 23 destinations in 2025.

0
active US DMFs
0
valid CEPs
1
registered plants
99
filings across 3 regulators

Registered plants

Site FDA FEI
Pune Maharashtra State, Nigeria Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ZAMRA (ZM) 49 None
NAFDAC (NG) 29 1
FDA (GH) 21 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $12.9M 13
2025 Not reported $61.8M 23
2024 Not reported $61.4M 20
2023 Not reported $55.0M 19

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 We do not publish the identity of any buyer.

Questions about Shalina Laboratories

Does Shalina Laboratories hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Shalina Laboratories. It does have 99 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Shalina Laboratories manufacture?
1 registered site is on record, in Nigeria (Pune Maharashtra State). Every site is listed on this page with the register it came from.
Which regulators recognise Shalina Laboratories's GMP?
Current GMP certificates are on record from NAFDAC (NG) and FDA (GH). 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