Research & Development
FDA Clears Meitheal Pharmaceuticals' Parent for Additional Manufacturing Capacity and Future Facility Expansion Plans for Production of Heparin Sodium Injection, USP
12 February 2020 - - The US Food and Drug Administration has approved a new vial manufacturing line at US-based generic injectables provider Meitheal Pharmaceuticals' majority shareholder, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.'s, Nanjing, China facility and the company has announced plans to expand manufacturing capacity, Meitheal said.

This approval doubles Meitheal's FDA-approved vial capacity to supply the US market with planned expansion expected to further increase Meitheal's supply capacity.

The new line and future expansion plans (10 total manufacturing lines) supports Meitheal's majority shareholder, NKF's commitment to ensuring capacity to supply the US market for years to come.
Nanjing, China Facility

The new FDA-approved vial line will have 50m units of new capacity, adding to NKF's existing vial line, for a combined capacity to produce 100m units.

A second pre-filled syringe line which is in the process of being added will have 100 m units of new capacity supplementing NKF's existing FDA approved pre-filled syringe line for a combined capacity to produce 200m units.

Construction of a second Nanjing, China facility, which is currently underway, will have 4 additional manufacturing lines.

50m units of new capacity will be added through a second vial line with products being submitted to the FDA for approval later this year, adding to NKF's existing vial line, for a combined capacity to produce 100 m units.

Meitheal's majority shareholder, NKF, is an FDA-approved manufacturer of both active pharmaceutical ingredients and finished dosage form, supplying 15-20% of the API heparin market worldwide.

Meitheal is NKF's exclusive commercialisation arm for the US market, ensuring consistent and dedicated supply of heparin.

Heparin is an intravenous or subcutaneous anticoagulant derived from porcine intestinal mucosa used to decrease the clotting ability of blood and help prevent harmful clots from forming in blood vessels.

Since 2017, Meitheal Pharmaceuticals has bridged critical gaps in the US healthcare market by supplying affordable generic injectables.

Its products range from antibiotics, anticoagulants, and muscle relaxants to drugs used in chemotherapy represents practical solutions for countless patients around the country, as well as Meitheal's commitment to their care.
Login
Username:

Password:


Related Headlines