2017 FDU Seminar: Doing Business in China
Transcript of 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]