Suppliers / Kwality Pharmaceuticals

Kwality Pharmaceuticals

India 197 employees Updated 9 July 2026

Kwality Pharmaceuticals is a finished-dose manufacturer based in India. It appears in 172 regulatory filings across 10 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), DIGEMAPS (DO) and NAFDAC (NG). Its GMP standing is certified by MCAZ (ZW), NAFDAC (NG) and ANVISA (Brazil), among 5 authorities. Customs aggregates show $24.3M of exports covering 2,287 molecules to 74 destinations in 2025.

0
active US DMFs
0
valid CEPs
6
registered plants
172
filings across 10 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
Punjab, United Arab Emirates Not on file
HIMACHAL PRADESH, India Not on file
PUNJAB, India Not on file
Amritsur, India Not on file
Kangra (H.P.), India Not on file
AMRITSAR, Nigeria Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 57 None
DIGEMAPS (DO) 48 None
NAFDAC (NG) 37 3
MINSA (CR) 14 None
UZPHARM (UZ) 7 None
INVIMA (CO) 3 None
MCAZ (ZW) None 3
ANVISA (Brazil) None 3
EMA None 2
FDA (GH) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $6.2M 41
2025 Not reported $24.3M 74
2024 Not reported $22.6M 72
2023 Not reported $20.0M 65

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 We do not publish the identity of any buyer.

Questions about Kwality Pharmaceuticals

Does Kwality Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Kwality Pharmaceuticals. It does have 172 filings with 10 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Kwality Pharmaceuticals manufacture?
6 registered sites are on record, in United Arab Emirates, India and Nigeria (Punjab, Himachal Pradesh and Punjab among others). Every site is listed on this page with the register it came from.
Which regulators recognise Kwality Pharmaceuticals's GMP?
Current GMP certificates are on record from MCAZ (ZW), NAFDAC (NG), ANVISA (Brazil), EMA 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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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