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LEVONORGESTREL AND ETH

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SPE2DP-26-T-4515Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The contract specifies the procurement of LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP, a hormonal contraceptive product regulated by the FDA, supplied by TEVA PHARMACEUTICALS USA, INC. Each package contains 168 tablets organized into six cycles of 28 tablets each, with a controlled sequence of active and inert tablets: six tablets with 50 mcg levonorgestrel and 30 mcg ethinyl estradiol, followed by five tablets with 75 mcg levonorgestrel and 40 mcg ethinyl estradiol, ten tablets with 125 mcg levonorgestrel and 30 mcg ethinyl estradiol, and seven inert tablets. The unit of issue is one package (PG) equaling 168 tablets, with a total order of two packages. The product must have a minimum of 21 months of remaining shelf life at the time of receipt by the first government activity, with a full 24-month shelf life from manufacture. Storage must be maintained at controlled room temperature between 20°C and 25°C (68°F to 77°F). Packaging and labeling must comply strictly with Medical Marking Standard No. 1A dated February 4, 2013, replacing all references to MIL-STD-129, and all units must be sealed in commercial containers that protect against damage and ensure safe, cost-effective delivery to Fort Campbell, TN, with delivery required within 20 days. The product is subject to federal acquisition regulations and requires pre-award confirmation through the EBS referral system, including manufacturer and product identification. The NSN is 6505012240176, the solicitation number is SPE2DP-26-T-4515, and the contract is awarded under a no-variance quantity agreement with FOB destination terms.

General Info

TEVA supplies two packages of 168-tablet hormonal contraceptive pills with strict shelf life, packaging, and delivery requirements to Fort Campbell.

Agency

Department Of Defense → MEDICAL SUPPLY CHAIN PHARM FSAView Agency

NAICS

325412 - Pharmaceutical Preparation ManufacturingView NAICS

Place of Performance

BLDG 5505A WICKHAM AVE, FORT CAMPBELL, KY, 42223-5000, US

Set-Aside

NONE

Documents

(1)

SPE2DP-26-T-4515.pdf

PDF

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Timeline

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Solicitation

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Organization & Contact Information

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AgencyDepartment Of Defense → MEDICAL SUPPLY CHAIN PHARM FSA
Contacts1 person available
OfficeUS
Organization / Agency
Department Of Defense → MEDICAL SUPPLY CHAIN PHARM FSA
View Agency Profile
Office AddressUS
Contacts
NICHOLAS QUIGLEY
contact@example.gov
+1 (555) 000-0000

Full Description

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LEVONORGESTREL AND ETHINYL ESTRADIOL TAB
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS,USP
RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT
RA001: THIS DOCUMENT INCORPORATES TECHNICAL AND/OR QUALITY REQUIREMENTS
(IDENTIFIED BY AN 'R' OR AN 'I' NUMBER) SET FORTH IN FULL TEXT IN THE
DLA MASTER LIST OF TECHNICAL AND QUALITY REQUIREMENTS FOUND ON THE WEB
AT:
http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx
FOR SIMPLIFIED ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE SOLICITATION ISSUE DATE OR THE AWARD DATE CONTROLS. FOR LARGE ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE RFP ISSUE DATE APPLIES UNLESS A SOLICITATION AMENDMENT INCORPORATES A FOLLOW-ON REVISION, IN WHICH CASE THE AMENDMENT DATE CONTROLS.
RQ011: REMOVAL OF GOVERNMENT IDENTIFICATION FROM NON-ACCEPTED SUPPLIES
.
RX ONLY
.
CONSISTS OF 6 CYCLES TOTAL WITH 28 TABLETS PER CYCLE COMPACT CONTAINING
IN SEQUENCE:
6 TABLETS LEVONORGESTREL 0.050 MG (50 MCG) AND ETHINYL ESTRADIOL 0.030
MG (30 MCG) FOLLOWED BY
5 TABLETS LEVONORGESTREL 0.075 MG (75 MCG) AND ETHINYL ESTRADIOL 0.040
MG (40 MCG) FOLLOWED BY
10 TABLETS LEVONORGESTREL 0.125 MG (125 MCG) AND ETHINYL ESTRADIOL 0.030
MG (30 MCG) FOLLOWED BY
7 TABLETS OF INERT INGREDIENTS
.
UNIT OF ISSUE IS A PACKAGE CONTAINING 168 EACH. (6 CYCLES OF 28 TABLETS
EACH).
.
TOTAL SHELF LIFE IS 24 MONTHS.
.
THERE SHALL BE A MINIMUM OF 21 MONTHS OF REMAINING SHELF LIFE
AT THE TIME OF RECEIPT BY THE FIRST GOVERNMENT ACTIVITY.
.
STORE AT 20° 25°C (68 ° 77°F). [SEE USP CONTROLLED ROOM
TEMPERATURE.]
.
LABELING AND MARKING MUST IN ACCORDANCE WITH
MEDICAL MARKING STANDARD NO. 1A DATED 4 FEBRUARY 2013
.
3/8/2016
.
.
This device or drug is regulated by the FDA. Note to Buyers: The contracting official shall send a referral in EBS to the product specialist for confirmation. Please include bidder name and bidder contact information, manufacturer name, manufacturer part number, and item description. 1 PG = 168 EA 1 PG = 168 EA
APPLICABLE TO ALL MEDICAL ACQUISITIONS:
PACKAGING AND PACKING SHALL BE COMMERCIAL AS SPECIFIED IN THE PROCUREMENT DOCUMENT.
SPE2DP-26-T-4515
SECTION B
EACH COMPLETE UNIT SHALL BE PROPERLY PACKAGED
IN A SUITABLE SEALED UNIT CONTAINER CAPABLE
OF PROTECTING THE CONTENTS FROM DAMAGE AND/OR
BREAKAGE.
UNITS SHALL BE PACKED IN SUITABLE COMMERCIAL
EXTERIOR (SHIPPING) CONTAINERS (EXPORT WHEN
NECESSARY) WHICH SHALL INSURE ACCEPTANCE AND
SAFE DELIVERY BY COMMON OR OTHER CARRIER, AT
THE LOWEST RATE, TO POINT OF DELIVERY CALLED
FOR IN THE CONTRACT OR ORDER.
MATERIAL MUST BE MARKED IAW MEDICAL MARKING
STANDARD NO. 1. THIS SUPERCEDES ALL REFERENCES
TO MIL-STD-129.
COPIES OF MEDICAL MARKING STANDARD NO. 1
(MMS NO. 1) MAY BE OBTAINED BY CONTACTING DLA
TROOP SUPPORT VIA EMAIL TO fssb@dla.mil. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
RD003, COVERED DEFENSE INFORMATION POTENTIALLY APPLIES
RS016: Shelf-life requirement RS001 for a TYPE I (CODE M) item with a shelf life of 24 months (non-extendable) applies to this item.
TEVA PHARMACEUTICALS USA, INC. 3V8D7 P/N NDC00555-9047-58
DLA issues this document using the DoD authorized unit of issue, please refer to the following URL to determine the corresponding ANSI X12 unit of issue.
https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.dla.mil%2FPortals%2F104%2FDocuments% 2FDLMS%2FeApplications%2FLogDataAdmin%2FUnitofIssueandPurchaseUnit.xlsx&wdOrigin=BROWSELINK
CLIN PR PRLI UI QUANTITY UNIT PRICE TOTAL PRICE.
0001 7017751665 0001 PG 2.000
NSN/MATERIAL:6505012240176
DELIVERY (IN DAYS):0020
DELIVER FOB: DESTINATION
QTY VARIANCE: PLUS 0% MINUS 0%
INSPECTION POINT: DESTINATION
ACCEPTANCE POINT: DESTINATION
PREP FOR DELIVERY:
PKGING DATA MIL-STD-2073-1E
SPECIAL NSN/Part Number: 6505-01-224-0176 Quantity: 2 PG Purchase Request: 7017751665QTY: 2 Delivery: 20 days ADO

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