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01 1Adare Pharma Solutions

02 1Chemtrade Solutions LLC

03 1EURAND

04 1F. Hoffmann-La Roche

05 1Glenmark Life Sciences

06 1Global Calcium

07 1India Phosphate

08 1K+S Kali GmbH

09 1Klinge Chemicals Ltd

10 1Macco Organiques, Spol. s.r o

11 1Mallinckrodt Pharmaceuticals

12 2Morton Salt

13 1Nandu Chemicals

14 1THINQ Pharma-CRO PVT Ltd

15 1VM Chemicals

16 1Wuhan Shiji Pharmaceutical

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PharmaCompass

02

PharmaVenue
Not Confirmed

02

PharmaVenue
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2013-04-26

Pay. Date : 2013-04-19

DMF Number : 5440

Submission : 1984-06-29

Status : Active

Type : II

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03

PharmaVenue
Not Confirmed

05

PharmaVenue
Not Confirmed

06

PharmaVenue
Not Confirmed

08

PharmaVenue
Not Confirmed

08

PharmaVenue
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2018-07-13

Pay. Date : 2018-05-25

DMF Number : 30511

Submission : 2016-10-03

Status : Active

Type : II

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10

PharmaVenue
Not Confirmed

K-Dur Manufacturers

A K-Dur manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of K-Dur, including repackagers and relabelers. The FDA regulates K-Dur manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. K-Dur API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of K-Dur manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

K-Dur Suppliers

A K-Dur supplier is an individual or a company that provides K-Dur active pharmaceutical ingredient (API) or K-Dur finished formulations upon request. The K-Dur suppliers may include K-Dur API manufacturers, exporters, distributors and traders.

click here to find a list of K-Dur suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

K-Dur USDMF

A K-Dur DMF (Drug Master File) is a document detailing the whole manufacturing process of K-Dur active pharmaceutical ingredient (API) in detail. Different forms of K-Dur DMFs exist exist since differing nations have different regulations, such as K-Dur USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A K-Dur DMF submitted to regulatory agencies in the US is known as a USDMF. K-Dur USDMF includes data on K-Dur's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The K-Dur USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of K-Dur suppliers with USDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.