This document provides contact information for Zhang Yu and lists the GMP status of several HEC factories and pharmaceutical products. It describes that Sunshine Lake Pharma Co., Ltd. and YiChang HEC ChangJiang Pharmaceutical Co., Ltd. have received GMP certifications from various regulatory authorities. It also notes that HEC Pharm Co., Ltd. and Ruyuan HEC Pharm Co., Ltd. facilities are GMP compliant and have been inspected by agencies including the FDA, EU, CFDA, and PMDA. The document contains lists of active pharmaceutical ingredients and finished dosage forms along with their respective GMP, dossier, and registration statuses.

1. HEC PHARM
Zhang Yu (Ms.)/ Dasha
Cell: +86 186 7692 1117
Email: SALES02@HECPHARM.BIZ; YU@DYG‐HEC.COM

2. GMP Status of HEC Factories
Contact: Zhang Yu (Ms.), +86 186 7692 1117, sales02@hecpharm.biz, yu@dyg‐hec.com.
Factory Name and Site GMP Compliance‐Dosage form Insp. Date Authority
Sunshine Lake Pharma Co., Ltd.
Guangdong, China
Product: Tablets, Capsules
EU ‐capsules, hard shell, tablets Nov, 2015 Landesamt fur Gesundheit und Soziales, Germany
US‐ Tablets, Capsules Sep, 2015 Food and drug administration (FDA), US
Belarus‐Tablets Feb, 2015 The ministry of Health of the Republic of Belarus
China‐ Hard capsule Nov, 2014 China food and drug administration (CFDA), China
China ‐ Tablets May, 2014 China food and drug administration (CFDA), China
YiChang HEC ChangJiang Pharmaceutical
Co., Ltd.
Hubei, China
Product: Tablets, Capsules, Granules/Dry
Suspension, Lyophilized Powder for
Injection; API; Insulin and its analogs
US ‐ API Mar, 2015 Food and drug administration (FDA), US
China ‐ Lyophilized Powder for injection Apr, 2014 China food and drug administration (CFDA), China
China ‐ Tablets, Capsules, Granules, Dry
Suspension, API
Feb, 2014 China food and drug administration (CFDA), China
China ‐ API Sep, 2013 China food and drug administration (CFDA), China
HEC Pharm Co., Ltd.
Hubei, China
Product: API (only macrolide)
China ‐ERY Apr, 2016 China food and drug administration (CFDA), China
EU‐API (AZM, CAM, ERY, ETH) Jul, 2015 BGV, Germany
Brazil ‐API (CAM) May, 2015 ANVISA, Brazil
US‐ API (ETH, ERY, CAM) Mar, 2015 Food and drug administration (FDA), US
Japan‐CAM Dec, 2014 PMDA, Japan
China‐API (ERY, CAM, AZM. ROX) Sep, 2013 China food and drug administration (CFDA), China
Japan‐AZM Jul, 2013 PMDA, Japan
Ruyuan HEC Pharm Co., Ltd.
Guangdong, China
Product: API, Excipients
US –API (Fingolimod, Linagliptin,
Rivaroxaban)
Sep, 2015 Food and drug administration (FDA), US
EU‐API (Azithromycin Monohydrate,
Rosuvastatin Calcium)
May, 2016 LAGeSo, Germany

3. Confidential Information7
ʻʫˁ ˇ̶̸̡̛̬̥̖̯̖̭̌̌̏̌́ ʽ̯̬̭̣̌̽
ˇ̨̬̥̼̌̌̏̔̚
ˉ̖̦̯̬ ʰ̨̛̭̭̣̖̦̔̏̌́ ̛ ˀ̛̛̯̌̏́̚
^ƵŶƐŚŝŶĞ >ĂŬĞ WŚĂƌŵĂ Ž͕͘ ƚĚ͘
ʿ̶̨̡̛̛̬̱̔͗ ˃̡̛̣̖̯͕̌̍ ʶ̪̭̱̣̼̌͘
'DW͗ ʿ̬̖̪̬̯̼̌̌ – ʥ̨̡̛̖̣̬̱̭̭̜͕ ʫ̨̡̛̬̪̖̜̭̜͕̏
ʤ̡̡̛̛̥̖̬̦̭̜̌ ̛ ʶ̡̛̛̯̜̭̜̌ 'DW͘
YiChang , ŚĂŶŐ:ŝĂŶŐ WŚĂƌŵĂĐĞƵƚŝĐĂů Ž͕͘ ƚĚ͘
ʿ̶̨̡̛̛̬̱̔͗ ˃̡̛̣̖̯͕̌̍ ʶ̪̭̱̣̼͕̌ ˁ̛̛̱̭̪̖̦͕̚ ʰ̶̡̛̛̦̻̖͖
ˈ̸̡̛̛̛̥̖̭̖ ̶̛̛̭̱̭̯̦͖̍̌
ʰ̛̦̭̱̣̦ ̶̛̛̭̱̭̯̦͕̍̌ ʰ̛̦̭̱̣̦ ̏ ̵̡̛̬̯̬̙̌̔̌͘
'DW͗ ʿ̬̖̪̬̯̼̌̌ - ʶ̡̛̛̯̜̭̜̌ 'DW͖
ˁ̶̛̛̱̭̯̦̍̌ - ʫ̨̡̛̬̪̖̜̭̜̏ ̛ ʶ̡̛̛̯̜̭̜̌ 'DW͘
WŚĂƌŵ
, WŚĂƌŵ Ž͕͘ ƚĚ͘
ʿ̶̨̡̛̛̬̱̔͗ ˁ̶̛̛̱̭̯̦̍̌ (̨̡̨̯̣̽ ̡̨̛̥̬̣̦̼̖̌̔)
'DW͗ ˁ̶̛̛̱̭̯̦̍̌ - ʫ̨̡̛̬̪̖̜̭̜̏ ̛ ʶ̡̛̛̯̜̭̜̌ 'DW͘
ZƵLJƵĂŶ , WŚĂƌŵ Ž͕͘ ƚĚ͘
ʿ̶̨̡̛̛̬̱̔͗ ˁ̶̛̛̱̭̯̦͕̍̌ ʰ̶̡̛̛̦̻̖͕ ʿ̨̣̱̯̖̬̼̖̏̔ ̪̬̖̪̬̯̼̌̌͘
'DW͗ ˁ̶̛̛̱̭̯̦̍̌ - ʤ̡̡̛̛̥̖̬̦̭̜̌ ̛ ʶ̡̛̛̯̜̭̜̌ 'DW͘

4. Pharmaceutical Active Ingredient (API)
 Welcome the local Drug Authority of customers to conduct on‐site GMP inspection at HEC facility! 
Zhang Yu (Ms.) / Dasha; sales02@hecpharm.biz; yu@dyg‐hec.com; +86 186 7692 1117.
Chemical API
No. Substance Name GMP Status CTD Dossier Status DMF and/or CEP
1 Alogliptin Benzoate Factory ‐ US GMP CTD dossier ‐ in preparation. DMF (2016 available)
2 Azilsartan Kamedoxomil Factory ‐ US and CN GMP US ‐ submitted. DMF 28452
3 Azithromycin Monohydrate Factory ‐ US GMP EU ‐ submitted, in evaluation; US ‐ submitted. DMF 28542; CEP 2014‐185
4 Benzbromarone Factory ‐ CN GMP with Product Name. China ‐ approved.
5 Besifloxacin Hydrochloride / (at RD Center now) CTD dossier ‐ in preparation. DMF (2016 available)
6 Daclatasvir / (at RD Center now) CTD dossier ‐ in preparation. DMF available
7 Entacapone Factory ‐ US and CN GMP EU ‐ approved; US ‐ submitted. DMF 27109; R0‐CEP 2013‐127‐Rev 00
8 Febuxostat Factory ‐ US and CN GMP CTD dossier ‐ in preparation. DMF (2016 available)
9 Fingolimod Hydrochloride Factory ‐ US GMP US ‐ submitted. DMF 28165
10 Fudosteine Factory ‐ CN GMP with Product Name. China ‐ approved.
11 LCZ696 / (at RD Center now) CTD dossier ‐ in preparation. DMF available in 2017
12 Ledipasvir Factory ‐ US GMP CTD dossier ‐ in preparation. DMF available
13 Linagliptin Factory ‐ US GMP US ‐ submitted. DMF 28785
14 Moxifloxacin Hydrochloride Factory ‐ US and CN GMP EU ‐ approved; US ‐ submitted. DMF 27394; R0‐CEP 2013‐225‐Rev 00
15 Oseltamivir phosphate Factory ‐ CN GMP with Product Name CTD dossier ‐ in preparation. DMF (2016 available)
16 Riociguat / (at RD Center now) CTD dossier ‐ in preparation. DMF (2016 available)
17 Rivaroxaban Factory ‐ US GMP US ‐ submitted. DMF 28786
18 Rosuvastatin Calcium Factory ‐ US GMP EU ‐ submitted, in evaluation; US ‐ submitted. DMF 29397; CEP 2015‐356
19 Sitagliptin Phosphate Factory ‐ US GMP EU ‐ submitted, in evaluation; US ‐ submitted. DMF 30170; CEP 2016‐015
20 Sofosbuvir Factory ‐ US GMP CTD dossier ‐ in preparation. DMF available
21 Solithromycin / (at RD Center now) CTD dossier ‐ in preparation. DMF (2016 available)
22 Suvorexant / (at RD Center now) CTD dossier ‐ in preparation. DMF (2016 available)

5. Pharmaceutical Active Ingredient (API)
 Welcome the local Drug Authority of customers to conduct on‐site GMP inspection at HEC facility! 
Zhang Yu (Ms.) / Dasha; sales02@hecpharm.biz; yu@dyg‐hec.com; +86 186 7692 1117.
No. Substance Name GMP Status CTD Dossier Status DMF and/or CEP
23 Telmisartan Factory ‐ CN GMP with Product Name. China ‐ approved.
24 Tenofovir Alafenamide Factory ‐ US and CN GMP CTD dossier ‐ in preparation. DMF (2016 available)
25 Tenofovir Disoproxil Fumarate / (at RD Center now) CTD dossier ‐ in preparation. DMF (2016 available)
26 Ticagrelor Factory ‐ US and CN GMP US ‐ submitted. DMF 28787
BIOSIMILAR API
No. Substance Name GMP Status CTD Dossier Status DMF and/or CEP
1 Recombinant Human Insulin Factory ‐ CN GMP in 2018. CN ‐ submitted, in evaluation. US ‐ submitted. DMF 27440
2 Insulin Glargine / CN ‐ submitted, in evaluation. US ‐ submitted in 2017. /
3 Insulin Aspart / CN ‐ submitted, in evaluation. /

6. Finished Dosage Form (FDF)
 Welcome the local Drug Authority of customers to conduct on‐site GMP inspection at HEC facility! 
Zhang Yu (Ms.) / Dasha; sales02@hecpharm.biz; yu@dyg‐hec.com; +86 186 7692 1117.
No. Name of API in FDF FDF Dosage Form FDF Strength FDF Registration Status GMP Status
1 Alogliptin Tablet 6.25/12.5/25 mg US: BE ‐ completed, CTD ‐ in preparation. Factory: EU, US and CN GMP
2 Amlodipine Besylate Tablet 5 mg China: approved. Factory: Chinese GMP with FDF name.
3 Aripiprazole Tablet 2/5/10/15/20/30 mg US: BE ‐ completed, CTD ‐ in preparation. Factory: EU, US and CN GMP
4 Aripiprazole Tablet 5/10/15/30 mg EU: BE ‐ completed, CTD ‐ in preparation. Factory: EU, US and CN GMP
5 Aripiprazole Oral Dispersible Tablet 10/15 mg EU, US: BE ‐ completed, CTD ‐ in preparation. Factory: EU, US and CN GMP
6 Azithromycin Oral Suspension 100/200 mg per 5 ml EU, US: BE ‐ completed, CTD ‐ in preparation. Factory: EU, US and CN GMP
7 Azithromycin Dihydrate Capsules 250 mg China: approved. Factory: Chinese GMP with FDF name.
8 Azithromycin Dihydrate Dry Suspension 100 mg China: approved. Factory: Chinese GMP with FDF name.
9 Azithromycin Dihydrate Dispersible Tablet 250 mg China: approved. Factory: Chinese GMP with FDF name.
10 Azithromycin Dihydrate Lyophilized Powder for Injection 250 mg (250,000 IU) China: approved. Factory: Chinese GMP with FDF name.
11 Azithromycin Dihydrate Film‐coated Tablet 250/500 mg Germany: approved. Factory: EU, US and CN GMP
12 Azithromycin Monohydrate Film‐coated Tablet 250/500/600 mg US: CTD will be submitted in 2016. Factory: EU, US and CN GMP
13 Benzbromarone Tablet 50 mg China: approved. Factory: Chinese GMP with FDF name.
14 Cetirizine Hydrochloride Dispersible Tablet 10 mg China: approved. Factory: Chinese GMP with FDF name.
15 Ciprofloxacin Hydrochloride Tablet 250 mg China: approved. Factory: Chinese GMP with FDF name.
16 Clarithromycin Tablet 250 mg China: approved. Factory: Chinese GMP with FDF name.
17 Clarithromycin Dispersible Tablet 250 mg China: approved. Factory: Chinese GMP with FDF name.
18 Clarithromycin Film‐coated Tablet 250/500 mg Germany: approved. Factory: EU, US and CN GMP
19 Clarithromycin Extended‐release Tablet 500 mg Germany: approved. Factory: EU, US and CN GMP
20 Clarithromycin Film‐coated Tablet 250/500 mg US: approved. Factory: EU, US and CN GMP
21 Clarithromycin Extended‐release Tablet 500 mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
22 Entacapone Film‐coated Tablet 200 mg Germany: approved. Factory: EU, US and CN GMP
23 Entacapone Film‐coated Tablet 200 mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
24 Escitalopram oxalate Tablet 5/10/20 mg EU: BE ‐ completed, CTD ‐ in preparation. Factory: EU, US and CN GMP

7. Finished Dosage Form (FDF)
 Welcome the local Drug Authority of customers to conduct on‐site GMP inspection at HEC facility! 
Zhang Yu (Ms.) / Dasha; sales02@hecpharm.biz; yu@dyg‐hec.com; +86 186 7692 1117.
No. Name of API in FDF FDF Dosage Form FDF Strength FDF Registration Status GMP Status
25 Esomeprazole Magnesium Gastro‐resistant Capsule 20/40 mg Germany: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
26 Esomeprazole Magnesium Delayed‐release Capsule 20/40 mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
27 Fingolimod Capsule 0.5 mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
28 Fluconazole Capsule 50 mg China: approved. Factory: Chinese GMP with FDF name.
29 Fudosteine Tablet 200 mg China: approved. Factory: Chinese GMP with FDF name.
30 Ganciclovir Lyophilized Powder for Injection 250 mg China: approved. Factory: Chinese GMP with FDF name.
31 Glipizide Capsule 5 mg China: approved. Factory: Chinese GMP with FDF name.
32 Ibuprofen Film‐coated tablet 400/600/800 mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
33 Irbesartan Film‐coated tablet 75/150/300 mg Germany: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
34 Linagliptin Tablet 5 mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
35 Linagliptin and Metformin Tablet 2.5 + 500/850/1000 mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
36 Lisinopril Tablet 10 mg China: approved. Factory: Chinese GMP with FDF name.
37 Metformin Tablet 500/850/1000 mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
38 Moxifloxacin HCl Film‐coated Tablet 400 mg Germany: approved. Factory: EU, US and CN GMP
39 Moxifloxacin HCl Film‐coated Tablet 400 mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
40 Mycophenolate Mofetil Lyophilized Powder for Injection 500 mg China: approved. Factory: Chinese GMP with FDF name.
41 Olanzapine Orally Disintegrating Tablet 5/10/15/20 mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
42 Olanzapine Film‐coated Tablet 2.5/5/7.5/10/15/20 mg Germany: approved. Factory: EU, US and CN GMP
43 Olanzapine Orodispersible Tablet 5/10/15/20 mg Germany: approved. Factory: EU, US and CN GMP
44 Olanzapine Film‐coated Tablet 2.5/5/7.5/10/15/20 mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
45 Olmesartan Medoxomil Tablet 10/20/40 mg Germany: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
46 Olmesartan medoxomil Tablet 5/20/40 mg US: BE ‐ completed, CTD ‐ in preparation. Factory: EU, US and CN GMP
47 Oseltamivir Phosphate Capsule 75 mg China: approved. Factory: Chinese GMP with FDF name.
48 Oseltamivir Phosphate Granule 15/25 mg China: approved. Factory: Chinese GMP with FDF name.

8. Finished Dosage Form (FDF)
 Welcome the local Drug Authority of customers to conduct on‐site GMP inspection at HEC facility! 
Zhang Yu (Ms.) / Dasha; sales02@hecpharm.biz; yu@dyg‐hec.com; +86 186 7692 1117.
No. Name of API in FDF FDF Dosage Form FDF Strength FDF Registration Status GMP Status
49 Oxaprozin Enteric‐coated Tablet 200 mg China: approved. Factory: Chinese GMP with FDF name.
50 Ozagrel sodium Lyophilized Powder for Injection 20 mg China: approved. Factory: Chinese GMP with FDF name.
51 Rivaroxaban Tablet 10/15/20 mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
52 Rosuvastatin Tablet 5/10/20/40 mg EU, US: BE ‐ completed, CTD ‐ in preparation. Factory: EU, US and CN GMP
53 Simvastatin Tablet 10/20 mg China: approved. Factory: Chinese GMP with FDF name.
54 Simvastatin Film‐coated Tablet 5/10/20/40/80 mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
55 Sitagliptin and Metformin Tablet 50 mg + 850/1000mg Germany: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
56 Sitagliptin phosphate Tablet 25/50/100 mg EU: BE ‐ completed, CTD ‐ in preparation. Factory: EU, US and CN GMP
57 Telmisartan Tablet 40/80 mg China: approved. Factory: Chinese GMP with FDF name.
58 Ticagrelor Tablet 90 mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP
59 Valacyclovir Hydrochloride Tablet 300 mg China: approved. Factory: Chinese GMP with FDF name.
60 Zidovudine Film‐coated Tablet 300mg US: CTD ‐ submitted, in evaluation. Factory: EU, US and CN GMP