FAR 52.215-6 Atenolol Tablets SPE2D2-19-D-0080.pdf

FAR 52.215-6 Place of Performance (OCT 1997)

(a) The offeror or respondent, in the performance of any contract resulting from this solicitation, intends, does not intend [check applicable block] to use one or more plants or facilities located at a different address from the address of the offeror or respondent as indicated in this proposal or response to request for information.

Pursuant to the clause above, please review and provide the required information:

1. The U.S. Food and Drug Administration (FDA) is the Government agency responsible for providing and enforcing pharmaceutical current Good Manufacturing Practices (cGMP) standards for pharmaceutical products included in this solicitation. Only offers from companies that have an acceptable cGMP status on record with the FDA for the facilities identified by the offeror in Paragraph 4 below will be considered for award. The FDA will evaluate a prospective offeror for DLA procurements only if the source has had a qualifying cGMP inspection within the previous two years. Before a contract can be awarded, any successful offeror’s (or its source’s) manufacturing facilities shall have a current acceptable cGMP status with FDA, or shall have had an acceptable report from the last FDA facility inspection on record. In the absence of a current cGMP evaluation, an offeror is required to include with its proposal documentation on the acceptable outcome of a FDA facility inspection that occurred less than two years prior to submission of the offer.

2. If the products are to be manufactured at more than one location, each manufacturing facility and each facility address shall be listed along with the products manufactured at the facility.

Subcontractors (i.e., packagers, labelers, etc.) that participate in the production of the products offered on this solicitation shall also be listed along with their addresses. All facilities described in this paragraph and listed below shall be substantially in compliance with applicable FDA cGMP standards prior to contract award.

3. Offeror shall identify below or by attachment (if additional space is needed), the products offered on this solicitation (products shall be identified by product name and by solicitation item number); whether the offeror manufactures the products; and/or whether the offeror is a distributor of the products offered.

4. If the finished products to be offered are of foreign manufacture, the complete name and address of the manufacturer shall be provided below. The offeror is also required to check the box below that is applicable to its offer. Please note that the information required below must be the name and address of the manufacturing facility, rather than the address of the foreign headquarters, distributor or agent.

☐OFFEROR IS THE MANUFACTURER (AT THE FOLLOWING LOCATIONS) OF THE PRODUCTS

OFFERED ON THIS SOLICITATION.

☐OFFEROR IS A DISTRIBUTOR OF THE PRODUCTS OFFERED ON THIS SOLICITATION. THE

PRODUCTS WILL BE MANUFACTURED BY THE FOLLOWING COMPANY AT THE FOLLOWING

LOCATIONS:

X

X

________Alphapharm PTY, Ltd.____________________________________________________ (Name of Manufacturing Company)

_ 1__________5 Garnet St. Carole Par___________k,_____________ QLD 4300, Australia (AUS)____________________________ (Street Address) (Post Office Address Not Acceptable)

(U.S.A. Point of Contact, e-Mail Address and U.S.A Telephone Number)

TABLETS, CAPSULES AND PILLS

Item Complete Address of Facility Where Ingredients are

Measured, Weighed, Mixed and Compounded

Point of Contact Including Phone Number

0001 – Atenolol 25MG 90 count bottle

0002 – Atenolol 25MG 1000 count bottle

0003 – Atenolol 50MG 90 count bottle

0004 – Atenolol 50MG 1000 count bottle

0005 – Atenolol 100MG 90 count bottle

0006 – Atenolol 100MG 1000 count bottle

Jill Dean, jill.dean@viatris.com, 800-796-9526

15 Garnet St Carole Park QLD 4300, Australia (AUS)

Jill Dean, 800-796-9526

15 Garnet St Carole Park QLD 4300, Australia (AUS)

15 Garnet St Carole Park QLD 4300, Australia (AUS)

15 Garnet St Carole Park QLD 4300, Australia (AUS)

15 Garnet St Carole Park QLD 4300, Australia (AUS)

15 Garnet St Carole Park QLD 4300, Australia (AUS)

Jill Dean, 800-796-9526

Jill Dean, 800-796-9526

Jill Dean, 800-796-9526

Jill Dean, 800-796-9526

Jill Dean, 800-796-9526

PACKAGING

Item Complete Address of Facility

Where Ingredients are Measured, Weighed, Mixed and Compounded

Point of Contact Including Phone Number

0001 – Atenolol 25MG 90 count bottle

0002 – Atenolol 25MG 1000 count bottle

0003 – Atenolol 50MG 90 count bottle

0004 – Atenolol 50MG 1000 count bottle

0005 – Atenolol 100MG 90 count bottle

0006 – Atenolol 100MG 1000 count bottle

PACKING

Item Complete Address of Facility Where Ingredients are

Measured, Weighed, Mixed and Compounded

Point of Contact Including Phone Number

0001 – Atenolol 25MG 90 count bottle

Golden State Medical Supply, Inc.

5187 Camino Ruiz Camarillo, CA 93012

Trudy Nickelson 805-477-9866 Ext. 135

Golden State Medical Supply, Inc.

5187 Camino Ruiz Camarillo, CA 93012

Golden State Medical Supply, Inc.

5187 Camino Ruiz Camarillo, CA 93012

Golden State Medical Supply, Inc.

5187 Camino Ruiz Camarillo, CA 93012

Golden State Medical Supply, Inc.

5187 Camino Ruiz Camarillo, CA 93012

Golden State Medical Supply, Inc.

5187 Camino Ruiz Camarillo, CA 93012

Golden State Medical Supply, Inc.

5187 Camino Ruiz Camarillo, CA 93012

Trudy Nickelson 805-477-9866 Ext. 135

Trudy Nickelson 805-477-9866 Ext. 135

Trudy Nickelson 805-477-9866 Ext. 135

Trudy Nickelson 805-477-9866 Ext. 135

Trudy Nickelson 805-477-9866 Ext. 135

Trudy Nickelson 805-477-9866 Ext. 135

0002 – Atenolol 25MG 1000 count bottle

0003 – Atenolol 50MG 90 count bottle

0004 – Atenolol 50MG 1000 count bottle

0005 – Atenolol 100MG 90 count bottle

0006 – Atenolol 100MG 1000 count bottle

New Drug Applications (NDA)

Offerors shall represent below information pertaining to FDA approval of New Drug Applications (NDA) or Abbreviated New Drug Applications (ANDA), when such approval is a prerequisite to marketing, and container/closure system information relative to product stability.

(If additional space is needed, the required information may be provided in an attachment to the offer.)

(a) NDA/ANDA.

Item ___________________________, FDA Approval File Number _______________________, Date of FDA approval _________________________.

(b) CONTAINER/CLOSURE SYSTEM MATERIALS.

(describe)

Golden State Medical Supply, Inc.

5187 Camino Ruiz Camarillo, CA 93012

Golden State Medical Supply, Inc.

5187 Camino Ruiz Camarillo, CA 93012

Golden State Medical Supply, Inc.

5187 Camino Ruiz Camarillo, CA 93012

Golden State Medical Supply, Inc.

5187 Camino Ruiz Camarillo, CA 93012

Golden State Medical Supply, Inc.

5187 Camino Ruiz Camarillo, CA 93012

Trudy Nickelson 805-477-9866 Ext. 135

Trudy Nickelson 805-477-9866 Ext. 135

Trudy Nickelson 805-477-9866 Ext. 135

Trudy Nickelson 805-477-9866 Ext. 135

Trudy Nickelson 805-477-9866 Ext. 135

073457 3002806388

1/24/1992