Laborchemie Apolda Gmbh

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01 Propiverine Hydrochloride (2)

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01 Jeil Pharmaceutical Co., Ltd. (1)

02 Samo Pharmaceutical Co., Ltd. (1)

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01 [Full process consignment manufacturing (manufacturer)] Laborchemie Apolda GmbH@[Full process consignment manufacturing (manufacturing client)] APOGEPHA Arzneimittel GmbH (1)

02 [Partial process consignment manufacturing (manufacturer)] Laborchemie Apolda GmbH@[Partial process consignment manufacturing (manufacturing requester)] APOGEPHA Arzneimittel GmbH (1)

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01 Germany (2)

List of Drug Master Files (KDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Laborchemie Apolda Gmbh to the Review Authority in Korea.

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APIs // Active Pharmaceutical Ingredients

5 APIs

5 USDMF

2 KDMF

DEVELOPMENTS

INSPECTIONS & REGISTRATIONS

2 FDA

LABORCHEMIE APOLDA GMBH

Propiverine Hydrochloride

Samo Pharmaceutical Co., Ltd.

2013-07-23

20130723-162-I-394-06

[Full process consignment...

Germany

DE-99510 Apolda, Utenbach...

Propiverine Hydrochloride

Jeil Pharmaceutical Co., Ltd.

2013-12-17

20130723-162-I-394-06(1)

[Partial process consignm...

Germany

DE-99510 Apolda, Utenbach...