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List of Drug Master Files (JDMF) for Lactulose Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Abbott Healthcare Products B. V. (1)

02 Danipharm A/S (1)

03 Fresenius Kabi iPSUM S. r. l. (2)

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01 Lactulose (2)

02 Lactulose Crystals (1)

03 Lactulose Syrup (1)

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01 Denmark (1)

02 U.S.A (1)

03 United Kingdom (2)

URL Supplier Web Content
219MF10056
C. J. van Houtenlaan 36 1381 CP Wee...
2015-04-21
2007-03-05
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URL Supplier Web Content
222MF10224
Englandsvej 350-356 DK-2770 Kastrup...
2010-09-07
2010-09-07
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URL Supplier Web Content
217MF11292
Piazza Maestri del Lavoro, 7 20063 ...
2014-05-02
2005-12-22
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URL Supplier Web Content
217MF11291
via Roma, n. 108 20051 Cassina de'P...
2014-04-02
2005-12-22
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Looking for 4618-18-2 / Lactulose API manufacturers, exporters & distributors?

Lactulose manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Lactulose API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lactulose manufacturer or Lactulose supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lactulose manufacturer or Lactulose supplier.

PharmaCompass also assists you with knowing the Lactulose API Price utilized in the formulation of products. Lactulose API Price is not always fixed or binding as the Lactulose Price is obtained through a variety of data sources. The Lactulose Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Lactulose

Synonyms

D-lactulose, Bifiteral, Cephulac, Chronulac, Constilac, Cholac

Cas Number

4618-18-2

Unique Ingredient Identifier (UNII)

9XH2P2N8EP

About Lactulose

A synthetic disaccharide used in the treatment of constipation and hepatic encephalopathy. It has also been used in the diagnosis of gastrointestinal disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p887)

Lactulose Manufacturers

A Lactulose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lactulose, including repackagers and relabelers. The FDA regulates Lactulose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lactulose 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 Lactulose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Lactulose Suppliers

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

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

Lactulose JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Lactulose Drug Master File in Japan (Lactulose JDMF) empowers Lactulose API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Lactulose JDMF during the approval evaluation for pharmaceutical products. At the time of Lactulose JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Lactulose suppliers with JDMF on PharmaCompass.

Lactulose Manufacturers | Traders | Suppliers

Lactulose Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Lactulose

Get in contact with the supplier of your choice:

  1. Abbott Laboratories
  2. DANIPHARM A S
  3. SCM Pharma
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.
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