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

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01 Auro Peptides Limited (1)

02 Chengdu Shengnuo Biopharm (1)

03 CordenPharma (1)

04 Hybio Pharmaceutical (2)

05 MSN Laboratories (2)

06 PolyPeptide Group (2)

07 Sun Pharmaceutical Industries Limited (1)

08 Teva API (1)

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01 LINACLOTIDE (6)

02 LINACLOTIDE (NON-STERILE BULK DRUG SUBSTANCE) (1)

03 LINACLOTIDE DRUG SUBSTANCE (2)

04 LINACLOTIDE NON-STERILE DRUG SUBSTANCE (1)

05 LINACLOTIDE [ROUTE CODE LE] (1)

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01 China (3)

02 Germany (1)

03 India (4)

04 Israel (1)

05 Switzerland (2)

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01 Active (11)

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01 Complete (6)

02 Blank (5)

URL Supplier Web Content
29708
Active
2015-09-22
Complete
2015-12-04
2015-09-18
II
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35812
Active
2021-04-06
Complete
2023-10-30
2023-09-19
II
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URL Supplier Web Content
24992
Active
2011-05-27
N/A
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URL Supplier Web Content
32314
Active
2017-12-28
N/A
II
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URL Supplier Web Content
31351
Active
2017-02-01
Complete
2017-08-01
2017-02-28
II
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URL Supplier Web Content
30421
Active
2016-03-29
N/A
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URL Supplier Web Content
25025
Active
2011-06-07
N/A
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URL Supplier Web Content
25021
Active
2011-06-01
N/A
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URL Supplier Web Content
30266
Active
2016-11-16
Complete
2016-12-23
2016-02-23
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URL Supplier Web Content
30274
Active
2016-03-10
Complete
2016-03-25
2016-02-12
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Looking for 851199-59-2 / Linaclotide API manufacturers, exporters & distributors?

Linaclotide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Linaclotide

Synonyms

Linzess, 851199-59-2, Chebi:68551, Md-1100, Constella, Cys cys glu tyr cys cys asn pro ala cys thr gly cys tyr (disulfide bridge: 1-6; 2-10; 5-13)

Cas Number

851199-59-2

About Linaclotide

Linaclotide is a synthetic, fourteen amino acid peptide and agonist of intestinal guanylate cyclase type C (GC-C), which is structurally related to the guanylin peptide family, with secretagogue, analgesic and laxative activities. Upon oral administration, linaclotide binds to and activates GC-C receptors located on the luminal surface of the intestinal epithelium. This increases the concentration of intracellular cyclic guanosine monophosphate (cGMP), which is derived from guanosine triphosphate (GTP). cGMP activates the cystic fibrosis transmembrane conductance regulator (CFTR) and stimulates the secretion of chloride and bicarbonate into the intestinal lumen. This promotes sodium excretion into the lumen and results in increased intestinal fluid secretion. This ultimately accelerates GI transit of intestinal contents, improves bowel movement and relieves constipation. Increased extracellular cGMP levels may also exert an antinociceptive effect, through an as of yet not fully elucidated mechanism, that may involve modulation of nociceptors found on colonic afferent pain fibers. Linaclotide is minimally absorbed from the GI tract.

Linaclotide Manufacturers

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

Linaclotide Suppliers

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

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

Linaclotide USDMF

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

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

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

Linaclotide Manufacturers | Traders | Suppliers

Linaclotide Manufacturers, Traders, Suppliers 1
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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