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

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01 Dr. Reddy's Laboratories (1)

02 Seqens (1)

03 Neuland Laboratories (1)

04 USV Private Limited (1)

05 ALP Pharm (1)

06 Aurobindo Pharma Limited (1)

07 Catalent Pharma Solutions (2)

08 Cipla (1)

09 Emcure Pharmaceuticals (1)

10 Glenmark Pharmaceuticals (1)

11 Helsinn Advanced Synthesis (1)

12 Kyongbo Pharmaceutical Co., Ltd (1)

13 Lianyungang Runzhong Pharmaceutical Co Ltd (1)

14 MSN Laboratories (1)

15 Qilu Pharmaceutical (1)

16 RANBAXY LABORATORIES LIMITED (1)

17 Rolabo Outsourcing, S.L. (1)

18 Teva API (2)

19 Tyche Industries Ltd (1)

20 Wockhardt (1)

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01 PALONOSETRON HC1 0.50 MG SOFTGELS (1.5 OVAL) (1)

02 PALONOSETRON HCL (1)

03 PALONOSETRON HYDROCHLORIDE (11)

04 PALONOSETRON HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE) (1)

05 PALONOSETRON HYDROCHLORIDE 0.50 MG SOFTGELS (1)

06 PALONOSETRON HYDROCHLORIDE USP (5)

07 PALONOSETRON HYDROCHLORIDE USP (NON STERILE API) (1)

08 PALONOSETRON HYDROCHLORIDE USP [ROUTE CODE PI] (1)

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01 China (3)

02 France (1)

03 India (11)

04 Israel (2)

05 South Korea (1)

06 Spain (1)

07 Switzerland (1)

08 U.S.A (2)

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01 Active (16)

02 Inactive (6)

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01 Complete (11)

02 Blank (11)

URL Supplier Web Content
23209
Active
2009-10-12
N/A
II
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16063
Active
2002-07-19
N/A
II
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URL Supplier Web Content
24661
Active
2011-02-19
Complete
2013-11-27
2012-12-26
II
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24497
Active
2010-12-23
Complete
2014-05-20
2014-03-10
II
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URL Supplier Web Content
23332
Active
2009-12-03
Complete
2013-04-23
2012-11-09
II
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URL Supplier Web Content
21749
Active
2008-07-01
N/A
II
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Looking for 135729-62-3 / Palonosetron API manufacturers, exporters & distributors?

Palonosetron manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Palonosetron

Synonyms

135729-62-3, Palonosetron hcl, Aloxi, Onicit, Palonosetron (hydrochloride), Rs-25259-197

Cas Number

135729-62-3

Unique Ingredient Identifier (UNII)

23310D4I19

About Palonosetron

Isoquinoline and quinuclidine derivative that acts as a 5-HT3 RECEPTOR antagonist. It is used in the prevention of nausea and vomiting induced by cytotoxic chemotherapy, and for the prevention of post-operative nausea and vomiting.

Palonosetron Manufacturers

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

Palonosetron Suppliers

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

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

Palonosetron USDMF

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

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

click here to find a list of Palonosetron suppliers with USDMF 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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