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List of Drug Master Files (DMF) of Lactitol Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 CULTOR FOOD SCIENCE INC (2)

02 Inalco SpA (1)

03 Particle Dynamics International, LLC. (1)

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01 DESTAB™ LACTITOL (1)

02 LACTITOL MONOHYDRATE (2)

03 LACTITOL, DIRECTLY COMPRESSIBLE FORM,(FINLAC DC) (1)

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01 Italy (1)

02 U.S.A (3)

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01 Active (2)

02 Inactive (2)

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01 Blank (4)

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13970
Inactive
1998-12-04
N/A
II
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13952
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1998-12-04
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27765
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2013-11-21
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31871
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2017-09-18
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Looking for 81025-04-9 / Lactitol API manufacturers, exporters & distributors?

Lactitol manufacturers, exporters & distributors 1

84

PharmaCompass offers a list of Lactitol 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 Lactitol manufacturer or Lactitol supplier for your needs.

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

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

API | Excipient name

Lactitol

Synonyms

81025-04-9, D-lactitol monohydrate, Lactitol (monohydrate), Lactitol hydrate, 4-o-beta-d-galactopyranosyl-d-glucitol monohydrate, Uh2k6w1y64

Cas Number

81025-04-9

Unique Ingredient Identifier (UNII)

UH2K6W1Y64

Lactitol Manufacturers

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

Lactitol Suppliers

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

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

Lactitol USDMF

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

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

click here to find a list of Lactitol suppliers with USDMF on PharmaCompass.

Lactitol Manufacturers | Traders | Suppliers

Lactitol Manufacturers, Traders, Suppliers 1
63

We have 3 companies offering Lactitol

Get in contact with the supplier of your choice:

  1. CULTOR FOOD SCIENCE INC
  2. Inalco SpA
  3. Particle Dynamics International, LLC.
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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