SAPTALIS PHARMACEUTICALS, LLC

File	View Page
Three-digit plan number (PN)	001
Effective date of plan	2015-01-01
Business code	325410
Sponsor’s telephone number	6312312751
Plan sponsor’s address	45 DAVIDS DR, HAUPPAUGE, NY, 11788

Signature of

Role	Plan administrator
Date	2024-05-28
Name of individual signing	MIA ZHOU

File	View Page
Three-digit plan number (PN)	001
Effective date of plan	2015-01-01
Business code	325410
Sponsor’s telephone number	6312312751
Plan sponsor’s address	45 DAVIDS DR, HAUPPAUGE, NY, 11788

Signature of

Role	Plan administrator
Date	2023-09-27
Name of individual signing	MIA ZHOU

File	View Page
Three-digit plan number (PN)	001
Effective date of plan	2015-01-01
Business code	325410
Sponsor’s telephone number	6312312751
Plan sponsor’s address	45 DAVIDS DR, HAUPPAUGE, NY, 11788

Signature of

Role	Plan administrator
Date	2023-10-02
Name of individual signing	MIAOZI ZHOU

File	View Page
Three-digit plan number (PN)	001
Effective date of plan	2015-01-01
Business code	325410
Sponsor’s telephone number	6312312751
Plan sponsor’s address	45 DAVIDS DR, HAUPPAUGE, NY, 11788

Signature of

Role	Plan administrator
Date	2023-10-02
Name of individual signing	MIA ZHOU

File	View Page
Three-digit plan number (PN)	001
Effective date of plan	2015-01-01
Business code	325410
Sponsor’s telephone number	6312312751
Plan sponsor’s address	45 DAVIDS DR, HAUPPAUGE, NY, 11788

Signature of

Role	Plan administrator
Date	2023-10-02
Name of individual signing	MIA ZHOU

File	View Page
Three-digit plan number (PN)	001
Effective date of plan	2015-01-01
Business code	325410
Sponsor’s telephone number	6312312751
Plan sponsor’s address	45 DAVIDS DR, HAUPPAUGE, NY, 117882038

Signature of

Role	Plan administrator
Date	2019-07-23
Name of individual signing	TATIANA AKIMOVA
Role	Employer/plan sponsor
Date	2019-07-23
Name of individual signing	TATIANA AKIMOVA

File	View Page
Three-digit plan number (PN)	001
Effective date of plan	2015-01-01
Business code	325410
Sponsor’s telephone number	6312312751
Plan sponsor’s address	45 DAVIDS DR, HAUPPAUGE, NY, 117882038

Signature of

Role	Plan administrator
Date	2019-09-20
Name of individual signing	TATIANA AKIMOVA
Role	Employer/plan sponsor
Date	2019-09-20
Name of individual signing	TATIANA AKIMOVA

File	View Page
Three-digit plan number (PN)	001
Effective date of plan	2015-01-01
Business code	325410
Sponsor’s telephone number	6312312751
Plan sponsor’s address	45 DAVIDS DRIVE, HAUPPAUGE, NY, 11788

Signature of

Role	Plan administrator
Date	2018-06-19
Name of individual signing	TATIANA AKIMOVA

File	View Page
Three-digit plan number (PN)	001
Effective date of plan	2015-01-01
Business code	325410
Sponsor’s telephone number	6312312751
Plan sponsor’s address	45 DAVIDS DRIVE, HAUPPAUGE, NY, 11788

Signature of

Role	Plan administrator
Date	2017-05-23
Name of individual signing	TATIANA AKIMOVA

File	View Page
Three-digit plan number (PN)	001
Effective date of plan	2015-01-01
Business code	325410
Sponsor’s telephone number	6312312751
Plan sponsor’s address	45 DAVIDS DRIVE, HAUPPAUGE, NY, 11788

Signature of

Role	Plan administrator
Date	2016-05-16
Name of individual signing	TATIANA AKIMOVA

Inspection Type	Complaint
Scope	Partial
Safety/Health	Health
Close Conference	2017-11-14
Case Closed	2018-05-15

Related Activity

Type	Complaint
Activity Nr	1275960
Safety	Yes
Health	Yes

Violation Items

Citation ID	01001A
Citaton Type	Serious
Standard Cited	19100134 C01
Issuance Date	2018-03-09
Abatement Due Date	2018-04-04
Current Penalty	1332.0
Initial Penalty	2217.0
Final Order	2018-04-03
Nr Instances	1
Nr Exposed	3
Gravity	1
FTA Current Penalty	0.0
Citation text line	1910.134(c )(1): A written respiratory protection program that included the provisions in 1910.134(c)(1)(i) - (ix) with worksite specific procedures was not established and implemented for required respirator use: a) At the worksite - employees with the title of technician, are provided with and required to wear filtering facepiece respirator, and half mask respirator and are not provided with the additional elements contained in the respirator program. The employer did not develop or implement a written respiratory program including training, medical evaluation, fit testing, facepiece seal protection, procedures for cleaning and storing and disinfecting of respirators, on or about 11/14/17. Note: The employer is required to submit abatement certification for this item in accordance with 29 CFR 1903.19. ABATEMENT NOTE: The written Respiratory Program must include the descriptions of how the following program elements, required by this regulation will be developed, implemented and conveyed to the employer's employees who use respirators: (i) Procedures for selecting respirators for use in the workplace. (ii) Medical evaluations of employees required to use respirators. (iii) Fit testing procedures for tight fitting respirators. (iv) Procedures for the proper use of respirators in routine and reasonably foreseeable emergency situations. (v) Procedures and schedules for cleaning, disinfecting, storing, inspecting repairing, discarding, and maintaining respirators. (vi) Procedures to ensure adequate air quality, quantity, and flow of breathing air for atmosphere-supplying respirators. (vii) Training of employees in the respiratory hazards to which they are potentially exposed during routine and emergency situations. (viii)Training of employees in the proper use of respirators, including put and removing them, any limitations on their use, and their maintenance; and (ix) Procedures for regularly evaluating the effectiveness of the program.
Citation ID	01001B
Citaton Type	Serious
Standard Cited	19100134 D01
Issuance Date	2018-03-09
Abatement Due Date	2018-04-04
Current Penalty	0.0
Initial Penalty	0.0
Final Order	2018-04-03
Nr Instances	1
Nr Exposed	3
Gravity	1
FTA Current Penalty	0.0
Citation text line	29 CFR 1910.134(d)(1)(i): The employer did not select and provide an appropriate respirator based on the respiratory hazard(s) to which the worker is exposed and workplace and user factors that affect respirator performance and reliability: a) At the worksite, the employer did not monitor the respiratory hazards to which the employees are exposed to; on or about 11/14/17. Note: The employer is required to submit abatement certification for this item in accordance with 29 CFR 1903.19.
Citation ID	01001C
Citaton Type	Serious
Standard Cited	19100134 E01
Issuance Date	2018-03-09
Abatement Due Date	2018-04-04
Current Penalty	0.0
Initial Penalty	0.0
Final Order	2018-04-03
Nr Instances	1
Nr Exposed	3
Gravity	1
FTA Current Penalty	0.0
Citation text line	29 CFR 1910.134(e)(1): The employer did not provide a medical evaluation to determine the employee's ability to use a respirator, before the employee was fit tested or required to use the respirator in the workplace: a) At the worksite; Employees are required to wear filtering facepiece respirator and half mask respirator without being provided with medical evaluation prior to the employee's use of the respirator in the workplace, on or about 11/14/17. Note: The employer is required to submit abatement certification for this item in accordance with 29 CFR 1903.19.
Citation ID	01001D
Citaton Type	Serious
Standard Cited	19100134 F02
Issuance Date	2018-03-09
Abatement Due Date	2018-04-04
Current Penalty	0.0
Initial Penalty	0.0
Final Order	2018-04-03
Nr Instances	1
Nr Exposed	3
Gravity	1
FTA Current Penalty	0.0
Citation text line	29 CFR 1910.134(f)(2): Employee(s) using tight-fitting facepiece respirators were not fit tested prior to initial use of the respirator: a) At the worksite; Employees are required to wear filtering facepiece respirator and half mask respirators without being fit tested prior to the initial use of the respirator, on or about 11/14/17. Note: The employer is required to submit abatement certification for this item in accordance with 29 CFR 1903.19.
Citation ID	01001E
Citaton Type	Serious
Standard Cited	19100134 K03
Issuance Date	2018-03-09
Abatement Due Date	2018-04-04
Current Penalty	0.0
Initial Penalty	0.0
Final Order	2018-04-03
Nr Instances	1
Nr Exposed	3
Gravity	1
FTA Current Penalty	0.0
Citation text line	29 CFR 1910.134(k)(3): Training was not provided prior to requiring employees to use a respirator in the workplace: a) At the worksite; Employees required to wear filtering facepiece respirator and half mask respirators were not provided with respiratory protectection training prior to being required to wear a respirator at the workplace; on or about 11/14/17. Note: The employer is required to submit abatement certification for this item in accordance with 29 CFR 1903.19.
Citation ID	01002
Citaton Type	Serious
Standard Cited	19100151 C
Issuance Date	2018-03-09
Abatement Due Date	2018-04-04
Current Penalty	1332.0
Initial Penalty	2217.0
Final Order	2018-04-03
Nr Instances	1
Nr Exposed	3
Gravity	1
FTA Current Penalty	0.0
Citation text line	29 CFR 1910.151(c): Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body was not provided within the work area for immediate emergency use. (a) At the work site; the eyewash was inoperable as valve handle was missing, on or about 11/14/17. Note: The employer is required to submit abatement certification for this item in accordance with 29 CFR 1903.19.
Citation ID	02001
Citaton Type	Other
Standard Cited	19101200 E01 I
Issuance Date	2018-03-09
Abatement Due Date	2018-04-04
Current Penalty	0.0
Initial Penalty	0.0
Final Order	2018-04-03
Nr Instances	1
Nr Exposed	3
FTA Current Penalty	0.0
Citation text line	1910.1200(e)(1)(i) A list of the hazardous chemicals known to be present was not provided to identify and reference the appropriate safety data sheet (the list may be compiled for the workplace as a whole or for individual work areas); (a) At the work site; the employer did not provde a list of identify and reference ; on or about 11/14/17. Note: The employer is required to submit abatement certification for this item in accordance with 29 CFR 1903.19.

Loan Status Date	2021-03-23
Loan Status	Paid in Full
Loan Maturity in Months	24
SBA Guaranty Percentage	100
Loan Approval Amount (at origination)	403630
Loan Approval Amount (current)	403630
Undisbursed Amount	0
Franchise Name	-
Lender Location ID	48270
Servicing Lender Name	JPMorgan Chase Bank, National Association
Servicing Lender Address	1111 Polaris Pkwy, COLUMBUS, OH, 43240-2031
Rural or Urban Indicator	U
Hubzone	N
LMI	N
Business Age Description	Existing or more than 2 years old
Project Address	HAUPPAUGE, SUFFOLK, NY, 11788-0001
Project Congressional District	NY-01
Number of Employees	34
NAICS code	325412
Borrower Race	Unanswered
Borrower Ethnicity	Unknown/NotStated
Business Type	Limited Liability Company(LLC)
Originating Lender ID	194093
Originating Lender Name	JPMorgan Chase Bank, National Association
Originating Lender Address	CHICAGO, IL
Gender	Unanswered
Veteran	Unanswered
Forgiveness Amount	406915.32
Forgiveness Paid Date	2021-02-10

Capabilities Statement Link	-
Phone Number	631-231-2751
Fax Number	-
E-mail Address	poli.dondeti@saptalis.com
WWW Page	-
E-Commerce Website	http://www.saptalis.com/
Contact Person	POLIREDDY DONDETI
County Code (3 digit)	103
Congressional District	01
Metropolitan Statistical Area	5380
CAGE Code	8L8A1
Year Established	2015
Accepts Government Credit Card	No
Legal Structure	LLC
Ownership and Self-Certifications	Self-Certified Small Disadvantaged Business
Business Development Servicing Office	NEW YORK DISTRICT OFFICE (SBA office code 0202)
Capabilities Narrative	Saptalis Pharmaceuticals, LLC is a specialty pharmaceutical company with a goal to create value through innovative R&D, industrial expertise to develop and manufacture complex dosage forms such as: non-sterile liquids (nano suspensions, micro-emulsions) and semi-solids (creams, gels, ointments etc.) and sterile suspensions, ointments, solutions etc. Saptalis Pharmaceuticals has a fully equipped Research & Development laboratory and state of the art manufacturing facility meeting FDA requirements to produce clinical batches and commercial products for US market. The team lead by Dr. Dondeti includes formulation scientists, analytical chemists, regulatory specialists, operations and quality assurance personnel.
Special Equipment/Materials	(none given)
Business Type Percentages	(none given)
Keywords	Saptalis, R&D, liquids, semi-solids, pharmaceuticals
Quality Assurance Standards	(none given)
Electronic Data Interchange capable	-

Current Principals

Name	Polireddy Dondeti
Role	President & CEO

SBA Federal Certifications

HUBZone Certified	No
Women Owned Certified	No
Women Owned Pending	No
Economically Disadvantaged Women Owned Certified	No
Economically Disadvantaged Women Owned Pending	No
Veteran-Owned Small Business Certified	No
Veteran-Owned Small Business Joint Venture	No
Service-Disabled Veteran-Owned Small Business Certified	No
Service-Disabled Veteran-Owned Small Business Joint Venture	No

Bonding Levels

Description	Construction Bonding Level (per contract)
Level	$0
Description	Construction Bonding Level (aggregate)
Level	$0
Description	Service Bonding Level (per contract)
Level	$0
Description	Service Bonding Level (aggregate)
Level	$0

NAICS Codes with Size Determinations by NAICS

Primary	Yes
Code	325412
NAICS Code's Description	Pharmaceutical Preparation Manufacturing
Buy Green	Yes

Export Profile (Trade Mission Online)

Exporter	No
Export Business Activities	(none given)
Exporting to	(none given)
Desired Export Business Relationships	(none given)
Description of Export Objective(s)	(none given)

Legal Name	SAPTALIS PHARMACEUTICALS LLC
DBA Name	-
Physical Address	45 DAVIDS DR , HAUPPAUGE, NY, 11788-2038, US
Mailing Address	45 DAVIDS DR , HAUPPAUGE, NY, 11788-2038, US
Phone	(732) 823-2802
Fax	-
E-mail	TANYA.AKIMOVA@SAPTALIS.COM

Safety Measurement System - All Transportation

Total Number of Inspections for the measurement period (24 months)	0
Driver Fitness BASIC Serious Violation Indicator	No
Vehicle Maintenance BASIC Acute/Critical Indicator	No
Unsafe Driving BASIC Acute/Critical Indicator	No
Driver Fitness BASIC Roadside Performance measure value	0
Hours-of-Service (HOS) Compliance BASIC Roadside Performance measure value	0
Total Number of Driver Inspections for the measurment period	0
Vehicle Maintenance BASIC Roadside Performance measure value	0
Total Number of Vehicle Inspections for the measurement period	0
Controlled Substances and Alcohol BASIC Roadside Performance measure value	0
Unsafe Driving BASIC Roadside Performance Measure Value	0
Number of inspections with at least one Driver Fitness BASIC violation	0
Number of inspections with at least one Hours-of-Service BASIC violation	0
Total Number of Driver Inspections containing at least one Driver Out-of-Service Violation	0
Number of inspections with at least one Vehicle Maintenance BASIC violation	0
Total Number of Vehicle Inspections containing at least one Vehicle Out-of-Service violation	0
Number of inspections with at least one Controlled Substances and Alcohol BASIC violation	0
Number of inspections with at least one Unsafe Driving BASIC violation	0

Circuit	Second Circuit
Origin	original proceeding
Jurisdiction	federal question
Jury Demand	Defendant demands jury
Demanded Amount	0
Termination Class Action	Missing
Procedural Progress	pretrial conference held
Nature Of Judgment	no monetary award
Judgement	missing
Arbitration On Termination	Missing
Office	2
Filing Date	2018-04-30
Termination Date	2018-07-02
Date Issue Joined	2018-06-06
Section	1338
Sub Section	PT
Status	Terminated

Parties

Name	SUN PHARMACEUTICAL INDU,
Role	Plaintiff
Name	SAPTALIS PHARMACEUTICALS, LLC
Role	Defendant

Circuit	Second Circuit
Origin	original proceeding
Jurisdiction	diversity of citizenship
Jury Demand	Plaintiff demands jury
Demanded Amount	6100000
Termination Class Action	Missing
Procedural Progress	no court action
Nature Of Judgment	no monetary award
Judgement	missing
Arbitration On Termination	Missing
Office	2
Filing Date	2024-10-28
Termination Date	2024-12-06
Section	1330
Status	Terminated

Parties

Name	KESIN PHARMA CORPORATION
Role	Plaintiff
Name	SAPTALIS PHARMACEUTICALS, LLC
Role	Defendant