ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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01 1ChemWerth Inc
02 1LGM Pharma
03 1Rochem International Inc
04 1Faran Shimi Pharmaceutical
05 1HRV Global Life Sciences
06 1Omgene Life Sciences Pvt. Ltd
07 1TAPI Technology & API Services
08 1Anthem Biosciences
09 1Apicore
10 1Auro Peptides Limited
11 1Aurobindo Pharma Limited
12 1BCN Peptides
13 1Chengdu Shengnuo Biopharm
14 1CordenPharma
15 1Guangzhou Tosun Pharmaceutical
16 2Hybio Pharmaceutical
17 1Jin Dun Medical
18 2MSN Laboratories
19 1Pellets Pharma Limited
20 1Piramal Pharma Solutions
21 2PolyPeptide Group
22 1Sandoo Pharmaceuticals and Chemcials Co.,Ltd
23 1Shenzhen JYMed Technology
24 1Smaart Pharmaceutticals
25 1Sun Pharmaceutical Industries Limited
26 1Teva Pharmaceutical Industries
27 1Viatris
28 1Blank
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01 7China
02 1Germany
03 11India
04 1Iran
05 2Israel
06 1Spain
07 2Switzerland
08 5U.S.A
09 1Blank
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01 11Active
02 1Inactive
03 19Blank
01 31Blank
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01 1231MF10090
02 30Blank
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01 1WC-0383A4
02 1WC-0443
03 29Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-03-25
Pay. Date : 2016-02-12
DMF Number : 30274
Submission : 2016-03-10
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-04
Pay. Date : 2015-09-18
DMF Number : 29708
Submission : 2015-09-22
Status : Active
Type : II
Date of Issue : 2022-09-07
Valid Till : 2025-06-10
Written Confirmation Number : WC-0443
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24992
Submission : 2011-05-27
Status : Active
Type : II
Registration Number : 231MF10090
Registrant's Address : 2075 North 55th Street Boulder, Colorado 80301-2880, U.S. S. A
Initial Date of Registration : 2019-04-16
Latest Date of Registration :
NDC Package Code : 12869-110
Start Marketing Date : 2012-08-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-23
Pay. Date : 2016-02-23
DMF Number : 30266
Submission : 2016-11-16
Status : Active
Type : II
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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.
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.
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.
We have 27 companies offering Linaclotide
Get in contact with the supplier of your choice: