Newgen Biotech USA

Manufacturer an Supplier of Enzymes and Beta Glucan. Lactase, Alpha-Galactosidase, Protease, Amylase, Cellulase, Lipase, Nattokinase, Serratiopeptidase

Location name	Address
Newgen Biotech USA	12901 Nicholson Road Suite 100 Farmers Branch, TX 75234 USA
Ningbo Newgen Biotech	No. 5 Rong Tai Road East Industrial Park Ningbo city, ZJ 315700 CHN

Type	Location	File name	Effective	Expiration
3rd Party Audit Report	Newgen Biotech USA	2023 Newgen GMP Audit Report Summary.pdf	7/20/2023	7/20/2024
FDA Registration	Newgen Biotech USA	FDA Registration Statement.pdf	5/19/2020	5/19/2022
FDA Registration	Ningbo Newgen Biotech	FDA Registration Statement.pdf	11/4/2020	11/1/2023
3rd Party Audit Certificate	Newgen Biotech USA	GMP Newgen exp 81322.pdf	8/13/2021	8/13/2022
Allergen Control Policy	Newgen Biotech USA	Newgen Biotech Ningbo - Allergen Control Statement.pdf	8/6/2021	8/6/2023
Foreign Supplier Verification Program (FSVP)	Newgen Biotech USA	Newgen Biotech USA - FSVP Statement_09072022.pdf	10/18/2022	10/17/2025
Letter of Guarantee	Ningbo Newgen Biotech	Newgen Biotech USA - Letter of Quality Guarantee.pdf	3/2/2023	3/1/2025
W-9	Newgen Biotech USA	Newgen Biotech USA_W9_Rev 2019.pdf	10/26/2020	10/26/2023
Recall/Emergency/Contact List	Newgen Biotech USA	Newgen Emergency Contact List.pdf	3/7/2023	3/6/2024
Recall/Emergency/Contact List	Ningbo Newgen Biotech	Newgen Emergency Contact List.pdf	1/25/2022	1/25/2023
HARPC Food Safety Plan (Facility)	Ningbo Newgen Biotech	Newgen HACCP_Exp Oct 13 2023.pdf	10/13/2020	10/13/2023
HARPC Food Safety Plan (Facility)	Newgen Biotech USA	Newgen HARPC Statement.pdf	10/26/2020	10/26/2023
Food Defense Plan Statement	Ningbo Newgen Biotech	Newgen ISO 9001_Exp Oct 13 2023.pdf	10/13/2020	10/13/2022
3rd Party Audit Report	Ningbo Newgen Biotech	Newgen Ningbo NSF GMP cerificate EXP Nov 30-2021.pdf		11/30/2021
3rd Party Audit Certificate	Ningbo Newgen Biotech	Newgen Ningbo NSF GMP cerificate EXP Nov 30-2021.pdf		11/30/2021
Separate Insurance Endorsements	Newgen Biotech USA	NotApplicable_SeparateInsuranceEndorsements.pdf	3/2/2023	3/1/2024
Supplier Agreement (Threshold Specific)	Newgen Biotech USA	NotApplicable_SupplierAgreementThresholdSpecific.pdf	3/2/2023	3/2/2024
VQE (If no full third party food safety audit report)	Ningbo Newgen Biotech	NotApplicable_VQEIfnofullthirdpartyfoodsafetyauditreport.pdf	3/2/2023	3/1/2024
Supplier Questionnaire	Newgen Biotech USA	Supplier Questionnaire.pdf	10/26/2020	10/26/2022
Sustainability (Level 1)	Newgen Biotech USA	Sustainability (Level 1).pdf	9/13/2019	9/12/2022
Sustainability (Level 2)	Newgen Biotech USA	Sustainability (Level 2).pdf	9/13/2019	9/12/2022

Newgen Biotech USA

Acid Protease 90,000 HUT/g

Alpha Amylase 100,000 DU/g

Alpha Galactosidase 10,000 GALU/g

Alpha Galactosidase 30,000 GALU/g

Amylase, Fungal 140,000 SKB/g

Beta Glucanase 5,000 BGU/g

Beta-Glucanase 1,000 BGU/g

Bromelain 3,000 GDU/g

Bromelain 600 GDU/g

Catalase 1500 Baker/G

Cellulase 110,000 CU/g

Cellulase 120,000 CU/g (TR)

Glucoamylase 1,000 AGU/g

Hemicellulase 6,500 HCU/g

Invertase 200,000 SU/g

Invertase Enzyme

Lactase 10,000 ALU/G

Lactase 100,000 ALU/g

Lactase 100,000 ALU/g

Lactase 100,000 ALU/g

Lactase 51,500 ALU/g

Lipase 15,000 U/g

Lipase 150,000 FIP/g (AN)

Lipase 5000 FIP/g

Maltase, Malt Barley 1000 DP/G

NUTR SUP CELLULASE ENZYME 120000 PWD 25 KG

NUTR SUP ENZYME INVERTASE 100000 PWD 25KG

Pancreatin 10X USP Powder

Papain 2000 USP/mg Powder

Papain 2000 USP/mg Powder

Papain 50,000 USP/mg

Pepsin 1:3000 Powder

Pepsin, Fungal 500 SAPU/g

Peptidase DPP IV (Peptidase Prolyl Endo) 300,000 HUT/g

Protease 300,000 HUT/g

Protease, Neutral 500,000 HUT/g

Serratiopeptidase 2,200 U/mg

Serratiopeptidase 80,000 U/g