Company profile for Lunan Pharmaceutical

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About

Lunan Pharmaceutical Group is an integrated pharmaceutical group setting production, scientific research and sale of traditional Chinese medicines, chemicals, biological products in one, a national innovative enterprise, China Torch Program key high-tech enterprise. The group is composed of seven subsidiary enterprises including Lunan Hope Pharmaceutical Co., Ltd., Lunan Better Pharmaceutical Co., Ltd., Shandong New Time Pharm...
Lunan Pharmaceutical Group is an integrated pharmaceutical group setting production, scientific research and sale of traditional Chinese medicines, chemicals, biological products in one, a national innovative enterprise, China Torch Program key high-tech enterprise. The group is composed of seven subsidiary enterprises including Lunan Hope Pharmaceutical Co., Ltd., Lunan Better Pharmaceutical Co., Ltd., Shandong New Time Pharmaceutical Co., Ltd., Lunan New Time Bio-Tech Co., Ltd., etc. It has been awarded the Top 500 Chinese Large Enterprise Group Competitiveness and Top 100 Taxpayers in Shandong Province for consecutive years.

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CONTACT DETAILS

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Country
Country
China
Address
Address
No. 209, Hongqi Road, Linyi City, Shandong Province, 276006
Telephone
Telephone
Linkedin
Linkedin
youtube
YouTube
Twitter
Twitter

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NEWS #PharmaBuzz

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219583

FDA
26 Feb 2026

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207375

FDA
28 Apr 2018

01

Montelukast Sodium

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IMCAS Asia
Not Confirmed
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Montelukast Sodium

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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02

Clavulanic Acid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IMCAS Asia
Not Confirmed
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Clavulanic Acid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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IMCAS Asia
Not Confirmed
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03

Clavulanic Acid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IMCAS Asia
Not Confirmed
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Clavulanic Acid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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IMCAS Asia
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04

Isoflurane

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IMCAS Asia
Not Confirmed
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Isoflurane

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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IMCAS Asia
Not Confirmed
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05

Linagliptin

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IMCAS Asia
Not Confirmed
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Linagliptin

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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IMCAS Asia
Not Confirmed
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06

Mosapride Citrate

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IMCAS Asia
Not Confirmed
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Mosapride Citrate

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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IMCAS Asia
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07

Tegafur

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IMCAS Asia
Not Confirmed
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Tegafur

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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IMCAS Asia
Not Confirmed
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08

Zoledronic Acid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IMCAS Asia
Not Confirmed
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Zoledronic Acid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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IMCAS Asia
Not Confirmed
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09

Clavulanic Acid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IMCAS Asia
Not Confirmed
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Clavulanic Acid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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IMCAS Asia
Not Confirmed
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10

Isosorbide Mononitrate

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

IMCAS Asia
Not Confirmed
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Isosorbide Mononitrate

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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IMCAS Asia
Not Confirmed
USDMF Inactive-api CEP/COS arrow-down JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT arrow-down
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USDMF

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03

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05

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07

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CEP/COS

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01

IMCAS Asia
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02

Isoflurane

CEP/COS

IMCAS Asia
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04

IMCAS Asia
Not Confirmed
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08

Sevoflurane

CEP/COS

IMCAS Asia
Not Confirmed
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KDMF

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01

IMCAS Asia
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Lunan Pharmaceutical

Registrant Name : Daewoong Bio Co., Ltd.

Registration Date : 2018-10-08

Registration Number : 20181008-117-G-151-11

Manufacturer Name : Shandong Luoxin Pharmaceutical...

Manufacturer Address : West Side of Yanbin Road, Economic Development Zone, Feixian Linyi, Shandong PR China...

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02

IMCAS Asia
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Lunan Pharmaceutical

Registrant Name : Otran Korea Co., Ltd.

Registration Date : 2026-01-08

Registration Number : 20260108-209-J-2094

Manufacturer Name : Shandong New Time Pharmaceutic...

Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong, China

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03

IMCAS Asia
Not Confirmed
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Lunan Pharmaceutical

Registrant Name : Otran Korea Co., Ltd.

Registration Date : 2025-01-13

Registration Number : 20230623-211-J-1342(A)

Manufacturer Name : Lunan New Time Bio-Tech Co., L...

Manufacturer Address : No.2, North Outer Ring Road, Feixian, County, Shandong Province, China

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04

IMCAS Asia
Not Confirmed
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Lunan Pharmaceutical

Registrant Name : Daehan Newpharm Co., Ltd.

Registration Date : 2023-06-23

Registration Number : 20230623-211-J-1342

Manufacturer Name : Lunan New Time Bio-Tech Co., L...

Manufacturer Address : No.2, North Outer Ring Road, Feixian, County, Shandong Province

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05

IMCAS Asia
Not Confirmed
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Lunan Pharmaceutical

Registrant Name : DM Co., Ltd.

Registration Date : 2025-03-11

Registration Number : 20250311-209-J-1803

Manufacturer Name : Shandong New Time Pharmaceutic...

Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China

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06

IMCAS Asia
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Lunan Pharmaceutical

Registrant Name : Otran Korea Co., Ltd.

Registration Date : 2020-07-03

Registration Number : 20200703-209-J-544

Manufacturer Name : Shandong New Time Pharmaceutic...

Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China

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07

IMCAS Asia
Not Confirmed
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Lunan Pharmaceutical

Registrant Name : Boryeong Co., Ltd.

Registration Date : 2014-04-10

Registration Number : 20120615-113-F-67-18(3)

Manufacturer Name : Shandong New Time Pharmaceutic...

Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China

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08

IMCAS Asia
Not Confirmed
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Lunan Pharmaceutical

Registrant Name : Boryeong Co., Ltd.

Registration Date : 2017-07-27

Registration Number : 20120615-113-F-68-17(3)

Manufacturer Name : Shandong New Time Pharmaceutic...

Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China

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09

IMCAS Asia
Not Confirmed
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Lunan Pharmaceutical

Registrant Name : Penmix Co., Ltd.

Registration Date : 2013-01-31

Registration Number : 20120615-113-F-68-17(2)

Manufacturer Name : Shandong New Time Pharmaceutic...

Manufacturer Address : No.1 North Outer Ring Road, Feixian County, Shandong Province

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10

IMCAS Asia
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Lunan Pharmaceutical

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2018-01-16

Registration Number : 20120615-113-F-69-16(1)

Manufacturer Name : Shandong New Time Pharmaceutic...

Manufacturer Address : No.1, North Outer Ring Road, Feixian County, Shandong Province, China

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FDF Dossiers

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01

Brand Name : BRIVARACETAM

IMCAS Asia
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Brand Name : BRIVARACETAM

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IMCAS Asia
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Lunan Pharmaceutical

Dosage Form : TABLET

Brand Name : BRIVARACETAM

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number : 219583

Regulatory Info :

Registration Country : USA

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02

Brand Name : BRIVARACETAM

IMCAS Asia
Not Confirmed
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Brand Name : BRIVARACETAM

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Lunan Pharmaceutical

Dosage Form : TABLET

Brand Name : BRIVARACETAM

Dosage Strength : 25MG

Packaging :

Approval Date :

Application Number : 219583

Regulatory Info :

Registration Country : USA

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03

Brand Name : BRIVARACETAM

IMCAS Asia
Not Confirmed
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Brand Name : BRIVARACETAM

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Lunan Pharmaceutical

Dosage Form : TABLET

Brand Name : BRIVARACETAM

Dosage Strength : 50MG

Packaging :

Approval Date :

Application Number : 219583

Regulatory Info :

Registration Country : USA

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04

Brand Name : BRIVARACETAM

IMCAS Asia
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Brand Name : BRIVARACETAM

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Lunan Pharmaceutical

Dosage Form : TABLET

Brand Name : BRIVARACETAM

Dosage Strength : 75MG

Packaging :

Approval Date :

Application Number : 219583

Regulatory Info :

Registration Country : USA

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Brand Name : BRIVARACETAM

IMCAS Asia
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Brand Name : BRIVARACETAM

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IMCAS Asia
Not Confirmed

Lunan Pharmaceutical

Dosage Form : TABLET

Brand Name : BRIVARACETAM

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number : 219583

Regulatory Info :

Registration Country : USA

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06

Brand Name : ISOFLURANE

IMCAS Asia
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Brand Name : ISOFLURANE

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Lunan Pharmaceutical

Dosage Form : LIQUID;INHALATION

Brand Name : ISOFLURANE

Dosage Strength : 99.9%

Packaging :

Approval Date : 2025-11-04

Application Number : 216527

Regulatory Info : RX

Registration Country : USA

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07

Brand Name : ISOSORBIDE MONONITRA...

IMCAS Asia
Not Confirmed
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Brand Name : ISOSORBIDE MONONITRA...

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Lunan Pharmaceutical

Dosage Form : TABLET, EXTENDED RELEASE...

Brand Name : ISOSORBIDE MONONITRATE

Dosage Strength : 120MG

Packaging :

Approval Date : 2022-04-29

Application Number : 214115

Regulatory Info : RX

Registration Country : USA

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Brand Name : ISOSORBIDE MONONITRA...

IMCAS Asia
Not Confirmed
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Brand Name : ISOSORBIDE MONONITRA...

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Lunan Pharmaceutical

Dosage Form : TABLET, EXTENDED RELEASE...

Brand Name : ISOSORBIDE MONONITRATE

Dosage Strength : 30MG

Packaging :

Approval Date : 2024-02-08

Application Number : 214115

Regulatory Info : RX

Registration Country : USA

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Brand Name : ISOSORBIDE MONONITRA...

IMCAS Asia
Not Confirmed
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Brand Name : ISOSORBIDE MONONITRA...

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IMCAS Asia
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Lunan Pharmaceutical

Dosage Form : TABLET, EXTENDED RELEASE...

Brand Name : ISOSORBIDE MONONITRATE

Dosage Strength : 60MG

Packaging :

Approval Date : 2024-02-08

Application Number : 214115

Regulatory Info : RX

Registration Country : USA

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Brand Name : MILRINONE LACTATE

IMCAS Asia
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Brand Name : MILRINONE LACTATE

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Lunan Pharmaceutical

Dosage Form : INJECTABLE;INJECTION

Brand Name : MILRINONE LACTATE

Dosage Strength : EQ 1MG BASE/ML

Packaging :

Approval Date : 2023-01-23

Application Number : 216373

Regulatory Info : RX

Registration Country : USA

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Contact Lunan Pharmaceutical and get a quotation

Lunan Pharmaceutical is a supplier offers 82 products (APIs, Excipients or Intermediates).

Find Montelukast Sodium bulk with DMF, CEP, JDMF offered by Lunan Pharmaceutical

Find Clavulanic Acid bulk with DMF, CEP offered by Lunan Pharmaceutical

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Find Linagliptin bulk with DMF, JDMF offered by Lunan Pharmaceutical

Find Mosapride Citrate bulk with DMF, JDMF offered by Lunan Pharmaceutical

Find Tegafur bulk with DMF, JDMF offered by Lunan Pharmaceutical

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Find Clavulanic Acid bulk with CEP offered by Lunan Pharmaceutical

Find Isosorbide Mononitrate bulk with CEP offered by Lunan Pharmaceutical

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