Molecules / Penciclovir

Penciclovir API manufacturers

CAS 39809-25-1 ATC D06BB06 Updated 9 July 2026
6
manufacturers with an active filing 5 of them hold a US DMF or a CEP
53
finished-dose makers across 18 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Torrent Pharmaceuticals

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for penciclovir, filing since 2021. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 20 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · NAI
GMP recognised in
20 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Alembic Pharmaceuticals

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for penciclovir, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
How this listing is sourced FDA, List of Drug Master Files
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04

Maithri Drugs

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for penciclovir, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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05

Registered with SFDA (Saudi Arabia) for penciclovir. Its 2023 FDA inspection closed as NAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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06

SMS Pharmaceuticals

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for penciclovir, filing since 2015. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · OAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
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3 more manufacturers hold filings for penciclovir

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

Maithri DrugsShanghai Pharma Group Changzhou Kony PharmaceuticalSMS Pharmaceuticals
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Finished-dose makers (9)

Teva Israel Viatris United States Padagis Israel Israel Amneal Pharmaceuticals NY United States Orion Finland Germed Farmaceutica Ltda Brazil Dongbang Future Tech & Life Co, Ltd (1731) South Korea Jasper Pharmaceutical Industries Egypt Medizen Pharmaceutical Industries Egypt

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

Who makes penciclovir?

Ask Fred which manufacturers are on record for penciclovir and what filings they hold.

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Also on this molecule

Recalls 1 Finished dose 9 Contract mfrs 0