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2017 FDU Seminar: Doing Business in China

2017 FDU Seminar: Doing Business in China

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2017 FDU Seminar: Doing Business in China

OPENING COMMENTS

• Respect for others and doing the “right thing”• Passion: for the industry, for the company

• Unwavering commitment to product quality• Win-win transactions: with customers,

suppliers, strategic partners• Dedication to products & causes that help

enrich the health & lives of other

Core Values

Rich ConnorEVP R&D, Quality and Regulatory Affairs

FROM $60MM TOWARD $600MM

Aland acquires IVC from Inverness Medical

2010

IVC acquires powder facility

and enters sports nutrition

market

2013

IVC acquires Perrigo nutrition becomes #1 for

store brand VMS

20162011

IVC opens3rd New Jersey

facility, newdedicated DC

IVC recognized as fastest growing

mass marketVMS company

2012

CNBC features IVC for its

investment in U.S.

manufacturing

2014

IVC has achieved the mission to become the #1 preferred supplier for store brand nutritional supplements in the U.S.

$6

0 M

illio

n$

60

0 M

illion

A future vision is to create greater value for nutritional supplements—Advanced science, better ingredients, improved delivery systems

U.S. OPERATIONS

Founded: 1955

Headquarters: Freehold, New Jersey

Ownership: Privately held

Employees: 900+ (not including temps)

Facilities: ~1 million square feet of U.S. based manufacturing, packaging, warehousing and distribution

Products: Dietary supplements, Sports nutrition, Functional foods, OTCs and Prescription drugs

Prime Forms: Tablets, Caplets, Chewables, Dissolving Tablets, Soft gels, Two piece capsules, Powders

Share Position: #1 U.S. private label VMS

U.S. FACILITIES

Freehold, New Jersey• Tablets/Caplets• Capsules• 255 employees

Freehold, New Jersey• Warehouse• Distribution• 47 employees

Irvington, New Jersey• Soft Gels• Rx/OTC• 122 employees

West coast operations

Mira Loma, California• Tablets/Caplets• Capsules• Powders• Packaging• Warehouse & Distribution122 employees

East coast manufacturing, packaging, warehousing and distribution

Powders

In-house labsPackaging

Greenville, South Carolina• Tablets/Caplets• Capsules• 300+ employees

FOCUS ON QUALITY

• Our highly tenured team follows proven SOPs and conducts rigorous and frequent tests on raw materials, finished products and packaging

• FDA audited and verified compliant with the latest cGMP’s• 21 annual audits by 3rd part organizations and marketers of VMS, OTC and Rx• USP/DSVP certified• UL/NSF cGMP Compliance (21 CFR Part 111) / Social Standards Compliance

In-house analytical & micro

labs

Delivery Forms CGMP Level QC Staff QA Staff

Freehold, NJ Solid Dose U.S. Dietary Supplements

√ √

Irvington, NJ Soft Gel U.S. Drug √ √

Greenville, SC Solid Dose U.S. Dietary Supplements

√ √

Mira Loma, CA

Powder, Solid Dose

U.S. Dietary Supplements

√ √

TOTAL USA 75 teammembers

90 team members

International Solid Dose, Powder, Soft

Gel

Meets/ExceedsU.S. Dietary

Supplements

>20 >20

Nearly 20% of our total headcount is dedicated to quality!

IVC Nutrition facilities are equipped with the latest state-of-the-art manufacturing equipment and are designed to exceed U.S. FDA 21 CFR Part 111 cGMP requirements, USP-DSVP <2750> and Chinese GMP

Tablets, 2pc Capsules, Soft Gels, Granulation and Powder Blending

3rd part certifications for quality, social accountability and environmental safety

1. SA8000:2001 - Social Accountability International

2. OHSAS GB/T 28001 - Occupational Health & Safety Management

3. ISO 9001 - Quality management system

4. ISO 14001 - Environmental management system

5. ISO 22000 - Food safety management system6. BRC Global Standard for Food Safety - British Retail Consortium

7. IFS - International Food Standard

8. USP - U.S.Pharmacopeia

9. NSF - National Sanitation Foundation

U.S. FDA audited facility

IVC Nutrition China720,000 sq. ft.

• On-site Lab• Manufacturing• Quality Testing• Warehousing• Distribution

CHINA FACILITIES

RETAIL & CONTRACT PRODUCTS

Category Strengths:- Multivitamins - CoQ10- Joint care - Nutritional powders- Botanicals - B12- Lutein/Vision - Letters: C, D, E

FOCUS ON QUALITY

Known for quality, we uphold our high standards in US and in China

Full supply chain traceability and transparency

Robust Supplier qualification process includes drill down to manufacturers (transparent supply chain) , audit history for each manufacturing site, proof of GMP compliance, processing information that allows us to determine whether or not a material can be claimed to be natural, GMO info, allergen info, secondary ingredients, etc.

Dietary ingredients must be an ODI or the subject of an NDI notification - New NDI draft guidance has been published

Authentic botanical products

FOCUS ON QUALITY

Retailers expect consistent quality Claim substantiation supported by well-controlled human studies, preferably

double blind, randomized, placebo controlled studies

Specific testing requirements, Stability data When appropriate, molecule specific analytical methods that allow us to

accurately quantitate claimed markers

Third party audits from credible auditors is strongly encouraged FSMA makes Foreign Supplier Validation (FSV) the responsibility of the importers

FROM US TO CHINA

China Challenges

Product Dependent / Industry Dependent

Rules and Regulations

Consumer Products Blue Hat registration for dietary supplements New Policy for Product registration (only allowed products) E-commerce (cross border) supply chain set up

Raw material Spec compliance Test methods Manufacturer qualification review Traceability Government environmental policies affect market price Anti-dumping raw materials impact the supply chain

FROM US TO CHINA

More on Health Food Registrations

Published and enforced by CFDA, effective July 1 2016 Allows filings and registrations

Registration CFDA organizes expert panel to conduct evaluation of product dossier for

safety, efficacy, purity, etc. of health food products excluding imparted supplements

For imports, the applicant is the manufacturer Valid for 5 years; re-apply 6 months before expiration

Filing CFDA or provincial FDA checks the dossier and archives for future reference.

Applies to imported nutritional supplements, which are reviewed by CFDA The applicant is also the manufacturer The validity of the certificate is permanent

FROM US TO CHINA

Common to registrations and filings

Applications for imports are always reviewed by CFDA

The applicants for imports are always the manufacturer

Except for exempted material, dossier requirements are identical

Active ingredient assays, safety testing and stability data are always required

The applicant (manufacturer) can make the appointment with CFDA or appoint a Chinese agent to deal with either registrations for filings

一站式跨境贸易供应链优化商

Contact

Shanghai Oujian Network Development Co., Ltd

Add:Floor 5, 1000 Pingliang Road, Tianke Guoji Building, Yangpu District,

Shanghai, China

Postcode: 200090

General manager of foreign trade departmenr:Sunny Sun

Tel:13601778331 021-35383328

Email:[email protected]