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List of all Manufacturers, Suppliers & Exporters of Lactulose API listed on PharmaCompass with details of regulatory filings

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01 Abbott Laboratories (2)

02 DANIPHARM A S (2)

03 Fresenius Kabi AB Brunna (1)

04 Fresenius Kabi Austria (5)

05 Fresenius Kabi USA, LLC (1)

06 Guangzhou Tosun Pharmaceutical (1)

07 Harman Finochem (1)

08 Inalco SpA (4)

09 Milei GmbH DE 70191 Stuttgart (1)

10 RELAX LTD (1)

11 Relax Limited (1)

12 SCM Pharma (2)

13 SOLVAY -Technology Solutions (3)

14 Syngars Technology (1)

15 Zambon Switzerland (1)

16 Zhejiang Tiantai Pharmaceutical (1)

17 Blank (2)

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01 Austria (6)

02 China (3)

03 Denmark (2)

04 Germany (4)

05 India (1)

06 Italy (4)

07 Malta (2)

08 Sweden (1)

09 Switzerland (1)

10 U.S.A (2)

11 United Kingdom (2)

12 Blank (2)

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01 Active (8)

02 Inactive (11)

03 Blank (11)

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01 Expired (1)

02 Valid (10)

03 Withdrawn by EDQM Failure to CEP procedure (1)

04 Withdrawn by Holder (1)

05 Blank (17)

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01 217MF11291 (1)

02 217MF11292 (1)

03 219MF10056 (1)

04 222MF10224 (1)

05 Blank (26)

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01 Blank (30)

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
8195
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
LACTULOSE CONCENTRATE USP
Issue/Submission Date
1989-09-08
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USDMF

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CEP/COS

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Written Confirmation

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Application Number
15253
R1-CEP 2005-023 - Rev 02
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
LACTULOSE SOLUTION USP
Lactulose, liquid
Issue/Submission Date
2001-02-16
2017-09-07
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
15254
R1-CEP 2002-236 - Rev 03
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
LACTULOSE CRYSTALS
Lactulose
Issue/Submission Date
2001-02-16
2017-10-11
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
5412
R0-CEP 2019-324 - Rev 00
Status
Active
Fees Unpaid
N/A
Valid
 
Filing Details
LACTULOSE 50% SYRUP
Lactulose, liquid, Process II, 670 ...
Issue/Submission Date
1984-02-07
2020-05-19
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USDMF

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Application Number
835
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
LACTULOSE SOLUTION
Issue/Submission Date
1964-09-09
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USDMF

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Application Number
11448
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
LACTULOSE CONCENTRATE
Issue/Submission Date
1995-04-11
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USDMF

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Application Number
12699
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
LACTULOSE CRYSTALLINE
Issue/Submission Date
1997-10-14
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USDMF

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Application Number
7682
R1-CEP 1999-145 - Rev 02
Status
Inactive
Fees Unpaid
N/A
Withdrawn by Holder
 
Filing Details
PURIFIED LACTULOSE SYRUP
Lactulose, liquid, 63.4% -70.0% w/v
Issue/Submission Date
1988-09-20
2014-05-13
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USDMF

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Application Number
9537
R0-CEP 2001-238 - Rev 01
Status
Inactive
Fees Unpaid
N/A
Expired
 
Filing Details
LACTULOSE CRYSTALS
Lactulose
Issue/Submission Date
1992-01-30
2004-11-15
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USDMF

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Application Number
11262
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
LACTULOSE CRYSTALS
Issue/Submission Date
1994-12-25
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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.

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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