Suppliers / Regal Pharmaceuticals

Regal Pharmaceuticals

Kenya 2 duplicate records merged Updated 9 July 2026

Regal Pharmaceuticals is a finished-dose manufacturer based in Kenya. It appears in 161 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with PPB (KE), TMDA (TZ) and ZAMRA (ZM). Its GMP standing is certified by DRAP (PK) and PPB (KE).

0
active US DMFs
0
valid CEPs
2
registered plants
161
filings across 3 regulators

Registered plants

Site FDA FEI
Nairobi, Kenya Not on file
rawat, Pakistan Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
PPB (KE) 97 1
TMDA (TZ) 45 None
ZAMRA (ZM) 19 None
DRAP (PK) None 1

Questions about Regal Pharmaceuticals

Does Regal Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Regal Pharmaceuticals. It does have 161 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Regal Pharmaceuticals manufacture?
2 registered sites are on record, in Kenya and Pakistan (Nairobi and Rawat). Every site is listed on this page with the register it came from.
Which regulators recognise Regal Pharmaceuticals's GMP?
Current GMP certificates are on record from DRAP (PK) and PPB (KE). 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