loader
Please Wait
Applying Filters...
Close
4

Bora CDMO Bora CDMO

X

List of Drug Master Files (KDMF) for Xiidra Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

Client Email Product
Menu
Filters Filter
Cross PopUp
FILTER :

filter

01 Glenmark Life Sciences Limited (1)

02 Glenmark Life Sciences Ltd (1)

03 MSN Life Sciences Private Limited (1)

04 Yeonseong Fine Chemical Co., Ltd. (1)

filter

01 Aging Life Science Co., Ltd. (1)

02 Kookjeon Pharmaceutical Co., Ltd. (1)

03 Mpeak Korea Co., Ltd. (1)

04 YS Life Science Co., Ltd. (1)

filter

01 Lipitegrast (4)

filter

01 India (3)

02 South Korea (1)

URL Supplier Web Content
Mpeak Korea Co., Ltd.
2021-08-11
Wed812-15-ND
Glenmark Life Sciences Lt...
India
Plot No.Z-103/ I, DAHEJ S...
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
Aging Life Science Co., Ltd.
2021-02-17
Number 434-29-ND
Glenmark Life Sciences Li...
India
Plot No. Z-103/I, SEZ Pha...
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
Kookjeon Pharmaceutical Co., Ltd.
2022-06-13
Number 173-41-ND
MSN Life Sciences Private...
India
Unit-ll, Sy.No.: Parts of...
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content
URL Supplier Web Content
YS Life Science Co., Ltd.
2023-07-12
2247-7-ND
Yeonseong Fine Chemical C...
South Korea
207 Sujeong-ro, Jangan-my...
ASK
US
PHARMACOMPASS
Upload
your Marketing & Sales content

Looking for 1025967-78-5 / Lifitegrast API manufacturers, exporters & distributors?

Lifitegrast manufacturers, exporters & distributors 1

61

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

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

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

API | Excipient name

Lifitegrast

Synonyms

1025967-78-5, Xiidra, Sar 1118, Sar-1118, Shp606, Shp-606

Cas Number

1025967-78-5

Unique Ingredient Identifier (UNII)

038E5L962W

About Lifitegrast

Lifitegrast is a FDA approved drug for the treatment of keratoconjunctivitis sicca (dry eye syndrome). It is a tetrahydroisoquinoline derivative and lymphocyte function-associated antigen-1 ( LFA-1) antagonist that was discovered through the rational design process. The ophthalmic solution was approved in July, 2016 under the trade name Xiidra. It has shown to protect the corneal surface and alleviate the symptoms of dry eye syndrome with fast onset of action and well tolerated profile in both local and systemic setting.

Xiidra Manufacturers

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

Xiidra Suppliers

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

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

Xiidra KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Xiidra Drug Master File in Korea (Xiidra KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Xiidra. The MFDS reviews the Xiidra KDMF as part of the drug registration process and uses the information provided in the Xiidra KDMF to evaluate the safety and efficacy of the drug.

After submitting a Xiidra KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Xiidra API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Xiidra suppliers with KDMF on PharmaCompass.

Xiidra Manufacturers | Traders | Suppliers

Xiidra Manufacturers, Traders, Suppliers 1
83

We have 3 companies offering Xiidra

Get in contact with the supplier of your choice:

  1. Glenmark Life Sciences
  2. MSN Laboratories
  3. Yonsung Fine Chemicals
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.
Post Enquiry
POST ENQUIRY